Table 1.
A summary of the RCTs in Stroke Rehabilitation in 2009.
| References | Time to randomization post-stroke | Set-up | Sample size (#) | Interventions | Main findings |
|---|---|---|---|---|---|
| Arms and Hand | |||||
| Dohle et al. [5] | ≤8 weeks post-stroke | Acute Rehabilitation Hospital | 36; Mirror therapy (MT)=18 Control=18 |
MT vs. control for 30 minutes a day, 5 days a week for 6 weeks | MT patients regained more distal function than controls. MT also improved recovery of surface sensation and hemineglect. These improvements were independent of the side of the lesioned hemisphere. |
| Liu et al. [7] | ≥7 days post-stroke | Acute hospitalization | 35; Mental Imagery (MI)=18 Control=17 |
The MI intervention was standardized practices and daily tasks broken down into chunking-self regulation-mental rehearsal strategies or control (functional rehabilitation) for 15 1 hour daily session for 3-week. | The MI patients showed better performances on 4 of 5 trained tasks vs. only 1 of 5 task in the FR patients (P=0.021). The MI patients also outperformed their FR counterpart on the 3 of 5 trained and 2 of 3 untrained tasks carried out in the novel environment. Thus MI imagery improved patients’ ability on performing the tasks they did not previously train on and in places different from the training environment. |
| Mangold et al. [10] | 23; Functional Electrical Stimulation (FES)=12 Control=11 |
FES or control 12 sessions over 4 weeks. | The EBI and CMSA arm score improved in both groups. The CMSA hand function and resistance to passive movement of finger and wrist flexors improved significantly in the FES group. Shoulder pain and gains on outcome measures were the same between the groups. | ||
| Chan et al. [11] | ≥6 months post-stroke | 20; FES=10 Control=10 |
15 training sessions comprising of Each session consisted of stretching activities (10 minutes), occupational therapy treatment (60 minutes), and FES with bilateral tasks (20 minutes) or sham FES. | After 15 training sessions, the FES group had significant improvement in FMA (P=.039), FTHUE (P=.001), and active range of motion of wrist extension (P=.020) compared to the control group. | |
| Klaiput et al. [12] | ≤6 months post-stroke | 20; Electrical stimulation = 10 Control = 10 |
2 hour session of simultaneous electrical stimulation over the median and ulnar nerves at the wrist vs. sham-stimulation (control). | Lateral and tip pinch strength increased in both groups (P<.05). However; increase in the pinch strength was greater in the peripheral sensory stimulation than the sham-control group (P<.05). The change Action Research Arm Test score was same in both groups (P>.05). | |
| Chae et al. [13] | ≥12 weeks post-stroke | Out-patient setting | 26; Electrical stimulation=13, Control=13 |
ES was 12 Hz vs. control 1 Hz 1 hour/day for 6 weeks followed by 18 hours of task specific training. | There was no treatment or time by treatment interaction effects for any of the outcome measures (primary-Fugl-Meyer Motor Assessment; secondary-Arm Motor Ability Test and delay and termination of EMG activity) at baseline, at the end of ES and task specific training, and at 1, 3, and 6 months follow-up between the 2 groups. |
| Lin et al. [17] | 6 to 40 months after stroke onset (mean 15 months) | Out-patient setting | 32; Constraint Induced Therapy (CIT)=16 Control=16 |
CIT for 2 hours daily 5 days per week for 3 weeks and restraint of the unaffected hand for 5 hours outside of the rehabilitation training) or a conventional intervention with hand restraint for the same duration. | CIT group exhibited better performance in motor function, level of functional independence, mobility, extended activities during daily life, and health-related quality of life after treatment as measured by Fugl-Meyer Assessment, Functional Independence Measure, Motor Activity Log, Nottingham Extended Activities of Daily Living Scale, and Stroke Impact Scale. |
| Lin et al. [18] | ≥6 months post-stroke | Out-patient setting | 60; CIT=20 BA =20 Control=20 |
Each group received intensive training for 2 hours/day, 5 days/week, for 3 weeks. | The BAT group exhibited greater gains in the proximal part of the FMA score than the modified CIT and control groups. Enhanced performance was found for the modified CIT group in the MAL, the FIM motor-subscale, and ADL/IADL of the SIS. |
| Woodbury [19] | ≥3 months | Out-patient setting | 11; Trunk restraint (TR)=6 No restraint (NR)=5 |
CIT for all enrolled patients (mitt on the unaffected hand for 90% of waking hours over 14 days and participated in 10 days/6 hours/day of supervised practice with TR or NR. | Both groups gained functional arm ability (P<.05 all tests). Post-training, the TR group had straighter reach trajectories (P=.000) and less trunk displacement (P=.001). The TR group gained shoulder flexion (P=.006) and elbow extension (P=.022) voluntary ranges of motion compared to the NR group. |
| Dromerick et al. [21] | ≤14 days post-stroke | Acute hospital | 52; CIT (n=35; low intensity=19, high intensity=16), Control (n=17) |
The low intensity CIT group received 2 hours of shaping therapy/day and wore mittens for 6 hours/day; high intensity CIT group received 3 hours of shaping therapy/day and wore mittens for 90% waking hours. The control group received compensatory techniques for ADLs, range of motion and strengthening. Both groups received 2 weeks of study-related treatments. | Both groups improved with time on the total ARAT score. There was a significant time x group interaction (F=3.1, p<0.01), such that the high intensity CIT group had less improvement at day 90. No significant differences were found between the dose-matched CIT and control groups at day 90. Head MRI showed no evidence of activity-dependent lesion enlargement. |
| Hammer et al. [22] | 30; Forced use=15 Control=15 |
Both group of patients received in 2-weeks of daily training on weekdays. In addition, the forced use group wore a restraining sling on the non-paretic arm for 6 hours/weekday. | The forced use group achieved greater improvements immediately post-intervention, but this was not significant. At 3-month follow-up both groups achieved 1.0 score point on both scales of the Motor Activity Log. | ||
| Harris et al. [24] | ≤2 weeks post-stroke | Acute rehabilitation unit | 103; GRASP=53 Control=50 |
GRASP group included exercises aiming for arm and hand strengthening, range of movement, gross and fines motor skills, and task oriented activities of daily living vs. Control included stroke and health education for 1 hour daily 6-days per week for 4-weeks. | The GRASP group showed greater improvement in upper limb function (CAHAI) compared to the control group (P<0.001). The GRASP group maintained this improvement at 5 months post-stroke. There was significant improvement in favor of the GRASP protocol for grip strength and paretic upper limb use. No serious adverse effects were experienced. |
| Housman et al. [25] | ≥6 months post-stroke | Outpatient setting | 28; T-WREX=14 Control=14 |
T-WREX a passive arm orthosis vs. table-top exercise treatment for 24 1-hour treatment sessions (3 times per week for 8 weeks). | All subjects significantly improved upper extremity motor control (Fugl-Meyer), active reaching range of motion (ROM), and self-reported quality and amount of arm use (Motor Activity Log) (P≤0.05). Improvements were maintained at 6 months. The T-WREX group maintained gains on the Fugl-Meyer better than controls at 6 months (P=0.04). Subjects reported a preference for T-WREX training. |
| Hu et al. [25] | ≥6 months post-stroke | Outpatient setting | 27; Continuous electromyography (EMG)-driven robot (interactive group, n=15) Passive motion device (passive group, n=12) |
20-session wrist training with a continuous electromyography (EMG)-driven robot (interactive group) or a passive motion device (passive group) completed within 7 consecutive weeks. | Significant improvements in Fugl-Meyer Assessment scores (shoulder/elbow) were found in the interactive group (P<.05). Significant decreases in the Modified Ashworth Scale (MAS) scores were observed in the wrist and elbow joints for the interactive group and in the wrist joint for the passive group (P<.05). These MAS changes were associated with the decrease in EMG activation level of the flexor carpi radialis and the biceps brachii for the interactive group (P <.05). However, both robot groups had no effect on the ARAT and FIM scores (p≥0.5). |
| Ellis et al. [27] | Outpatient setting | 14; Experimental group=7, Control group=7 |
The experimental group received a total of 3 sessions/week over an 8-week period with a progressive increase by 25% of arm weight actively supported by the participant while reaching to various outward targets. The control group practiced the same reaching tasks with matched frequency and duration with the weight of the arm supported. | Change scores for work area at 9 different loads were larger for the experimental group at the limb-loading levels of 50%, 100%, 125% and 175% (p≤0.05) Thus progressive shoulder abduction loads helped reach ROM against gravity. | |
| Lakse et al. [28] | ≥2 months post-stroke | In-patient rehabilitation setting | 38; Injection group=21 Control group=17 |
Injection was a mixture of 1 ml triamcinolone and 9 ml of prilocain vs. no injection. Both groups received conventional therapy plus TENS. | The range of shoulder motion and shoulder pain scores improved in both group of patients, however; improvement was more significant in the injection group. Barthel scores improved equally in both groups. Changes in the Brunnstrom upper-extremity and modified Ashworth scores between both groups was similar. |
| Kim et al. [29] | ≥3 months post-stroke | 10; tDCS=5, Sham=5 |
1 mA of tDCS for 20 mins vs. sham for 30 secs | Finger acceleration measurement and Box and Block test improved after anodal tDCS compared with sham stimulation (P<0.05). This improvement lasted for 30 minutes for the finger acceleration measurement and 60 minutes for the Box and Block test (P<0.05) with no effect on attention and fatigue. | |
| Stoykov et al. [30] | ≥6 months post-stroke | 24; Bilateral group=12 Unilateral=12 |
Bilateral group subjects practiced bilateral symmetrical activities, whereas the unilateral group performed the same activity with the affected arm only. The activities consisted of reaching-based tasks that were both rhythmic and discrete. Both groups received 1-hour session 3 times per week for 8 weeks (24 sessions). | Both groups improved on the MAS, MSS and measures of strength, however; the bilateral group had greater improvement on the Upper Arm Function scale (a subscale of the MAS-Upper Limb Items). | |
| Legs | |||||
| Mirelman et al. [31] | 18; Robot virtual reality (VR)=9 Robot alone=9 |
for 4-weeks | Greater changes in velocity and distance walked were demonstrated for the group trained with the robotic device coupled with the VR than training with the robot alone. Similar improvements in the distance walked and number of steps taken in the community were for the robot coupled with the VR group. These differences were maintained at 3 months’ follow-up. | ||
| Kim et al. [32] | ≥12 months post-stroke | 24; Virtual Reality (VR)=12, Control group=12 |
40 minutes a day, 4 days a week for 4 wks of conventional therapy plus 30 minutes of additional VR or no therapy (control). | In the balance test, the VR group had improved Berg Balance Scale scores, balance and dynamic balance angles (ability to control weight shifting) compared with the controls (P<0.05). In the gait performance test, the VR group showed improvements in velocity, Modified Motor Assessment Scale scores, cadence, step time, step length, and stride length (P<0.05). | |
| Hidler et al. [33] | <6 months post-stroke | 63; Lokomat=33 Conventional=30 |
24 1-hour sessions of either Lokomat or conventional gait training. | Participants who received conventional gait training experienced greater gains in walking speed (0.25±0.03 m/s vs. 0.12±0.03 m/s, P=.002) and distance (274±35.4 ft vs. 164.6±32.5 ft, P=.03) than those trained on the Lokomat both immediately post-training and at the 3-month follow-up evaluation. | |
| Franceschini et al. [34] | <6 weeks post-stroke | Acute rehabilitation unit | 97; Partial body weight support treadmill =52 Conventional over-ground gait training=45 |
Partial body weight support on a treadmill vs. conventional over-ground gait training. | Both groups showed improvement in all outcome measures (P<0.0063) at the end of the treatment and at follow-up. After treatment, all patients were able to walk. |
| Au-Yeung et al. [37] | >6 months post-stroke | Community setting | 136; Tai Chi group=74 Control group=62 |
Short form Tai Chi exercises vs. control group practicing general exercises for 12 weeks. Each week, 1 hour of group practice supplemented by 3 hours of self-practice. | The Tai Chi group showed greater COG excursion amplitude in leaning forward, backward, and toward the affected and non-affected sides (P<.05). Faster reaction time in moving the COG toward the non-affected side (P=.014) in the end-program and follow-up assessments compared to controls. Neither group improved in Timed-up-and-go scores. |
| Ng et al. [38] | 1 year post-stroke | Community setting | 109; (1) transcutaneous electrical nerve stimulation (TENS, n=28), 2) TENS + exercise (n=27), (3) placebo stimulation + exercise (n=25), (4) control group (n=29) |
TENS group received 60 minutes of electrical stimulation at 100 Hz using a square pulse stimulator with electrodes placed at 4 acupuncture points on the lower limbs. The TENS + exercise group and placebo stimulation + exercise group received 60 minutes of exercises, after receiving 60 minutes of electrical and placebo stimulation respectively. | Combined TENS + exercise group showed greater absolute and percentage increases in gait velocity on GAITRite II walkway system (P<0.01), reduction in timed up and go scores (P<0.01) and more distance covered in the 6-minute walk test (P<0.01) from week 2 onwards. |
| Mudge et al. [39] | 6 months post-stroke | Out-patient clinic | 60; Exercise group=31, Control group=27 |
Exercise group had 12 sessions (30 minutes 3 times per week for 4-weeks) in clinic-based rehabilitation delivered in a circuit class designed to improve walking or the control group received a comparable duration of group social and educational classes. | Exercise group covered greater distance for the 6-minute timed walk test than the control group immediately after the intervention (P=.030) but that this effect was not retained 3 months later. The exercise and control groups had different gait speed (P=.038) and scores on the Rivermead Mobility Index (P=.025) at the 3-month follow-up. |
| Miscellaneous | |||||
| Verheyden et al. [40] | 33; Experimental group=17 Control=16 |
Experimental group received additional 10 hours of individual and supervised trunk exercises for 30 minutes, 4 times a week, for 5 weeks. | Post-treatment, there was a improvement in the experimental compared to the control group for the dynamic sitting balance subscale and for the selective lateral flexion initiated from the upper and lower part of the trunk, (P=.002, effect size=1.16). The study concluded that trunk exercises in addition to conventional therapy, improved sitting balance and selective trunk movements. | ||
| Jianjun et al. [41] | Community based | 737; Exercise=377 No exercise=360 |
45 minute standardized community-based exercise program 3 times per week vs. no additional exercise for 5 months. | After 5-months, the CNFDS scores for the cerebral infarction in the rehabilitation group improved by 6.77 vs. 1.57 for the control group. Similarly, the CNFDS scores for hemorrhage in the rehabilitation group were 7.99 vs. 5.34 for the control group. This implied a difference in improvement of 5.2 in the cerebral infarction and 2.65 in the hemorrhage groups. This study showed the beneficial effect of an ongoing standardized community-based exercise program to further improve the neurological function of stroke patients. | |
| Roth et al. [43] | 30; Explorative Saccade Training (EST)=15 Flicker Stimulation Training (FT)=15 |
Either EST, a digit-search task or FT, blind-hemifield stimulation by flickering letters on a computer screen for 6 weeks. | Patient’s assigned to EST group had a reduced (post/pre, 47%) digit-search response time (RT) for the blind side and (post/pre, 23%) reduced natural search RT on the blind side. After FT, both sides RT remained same. Only patients in the EST group increased the number of fixations during natural scene exploration toward the blind and decrease on the seeing side (follow-up/pre difference, 238%). Visual field size remained unchanged after both treatments. Patient’s in the EST group self-reported improvement in social domains. | ||
| Serino et al. [47] | 20; Prism adaptation (PA)=10 Without prisms, i.e., neutral pointing (NP)=10 |
Prism adaptation (PA) compared to visuomotor training without prisms, i.e., neutral pointing (NP) 10 daily sessions over a 2 week period. | Visuo-spatial abilities (pointing at a visual target with their right index finger) improved after both PA and NP treatment; however, the improvement was greater in the patients in the PA than in the patients in the NP group. Patients in the NP group submitted to PA, improved to the level reached by patients in the PA group, i.e., to non-pathological scores. This beneficial effects of PA persisted a 1 month from the end of treatment. | ||
| Cumming et al. [48] | ≤2 days of their acute stroke | Acute hospital stroke unit | 71; Very early mobilization (VEM)=38 Standard care (SC)=33 |
VEM (implied initial mobilization as soon as practical after recruitment preferably within 24 hours of stroke symptom onset) vs. SC. | SC group patients with neglect had longer hospital stays (median, 11d) than those without neglect (median, 4d); however, there was no difference in length of stay between patients with and without neglect in the VEM group (median, 6d in both). Post-stroke patients with neglect were less likely to return home. 87% post-stroke patients with neglect had poor outcome as measured by the mRS at 12 months compared to 45% of patients without neglect. |
| Si Hyun Kang et al. [49] | 16; Computer interface with motion tracking technology (CAMSHIFT)=8 Psychological Software Service (PSS) CogRehab program=8 |
CAMSHIFT vs. PSS CogRehab program for 3 sessions per week, 30 minutes per session for 4-weeks. | After training, the mean (SD) Motor-free Visual Perception Test score increased in both experimental (from 65.8 (19.5) to 77.8 (28.7)) and control groups (from 68.3 (11.4) to 74.1 (14.8)) (P<0.01). Modified Barthel Index score increased in both groups, with the experimental group recording a higher increase. | ||
| Cacchio et al. [51] | >3 months post-stroke | Rehabilitation center | 48; Mirror therapy=24 Placebo control group=24 |
30 minutes of Mirror therapy in the first 2-weeks followed by 1-hr per week for next 2-weeks vs. controls, who performed the same exercises for the same duration with the reflecting side of the mirror covered | The mean scores of both the primary end points (reduction in the visual analogue scale score of pain at rest, on movement, and brush-induced tactile allodynia) and secondary end points (Wolf Motor Function Test and Motor Activity Log) improved in the mirror group (P<.001). No improvement was observed in any of the control group values (P>.001). This difference after treatment (P<.001) was maintained at the 6-month follow-up in the mirror compared to the control group. |
| Barker-Collo et al. [54] | 18 months post-stroke | Out-patient setting | 78; APT=38, Standard care alone=40 |
APT for 1 hour daily for 4 weeks up to 30 hours or standard care alone. | APT resulted in a greater improvement on the primary outcome than standard care (P<0.01). Change on the Cognitive Failures Questionnaire showed a trend (P=0.07) favoring the APT group. |
| Winkens et al. [57] | >3 months post-stroke | Rehabilitation Center (both in-patient and out-patient setting) | 37; TPM=20, Control=17 |
10 hours of TPM treatment vs. stroke education | Both groups showed decline in the number of complaints on the Mental Slowness Questionnaire. This decline was present at 3 months. At 3 months, speed of performance on the Mental Slowness Observation Test was higher in the TPM group compared to the usual-care group (P=.01). |
| Quaney et al. [60] | >6 months post-stroke | 38; Aerobic Exercise (AEX) group=19), Stretching Exercise (SE) group=19) |
AEX group performed progressive resistive stationary bicycle training at 70% maximal heart rate and the SE group performed stretches at home. Both groups exercised 3 times a week (45-minute sessions) for 8 weeks. | The VO(2)max, serial reaction time task (“procedural motor learning”) and information processing speed improved at “Post” with AEX (p<.05). AEX also improved predictive force accuracy for a precision grip task requiring attention and conditional motor learning of visual cues. Ambulation and sit-to-stand transfers were faster in the AEX group at “Post” (p<.038), with balance control significantly improved at “Retention” (p<.041). EF measurements were the same between the 2 groups. AEX improved mobility and cognitive EF processing speed. | |