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. 2017 Sep 5;7(3 Suppl):175S–194S. doi: 10.1177/2192568217703084

Table 2.

Characteristics of Studies Reporting Different Rehabilitation Strategies After SCI.

Study (Year) Study Design Demographics Inclusion/Exclusion Criteria Treatment Details Baseline Patient Characteristics Follow-up (% Followed) Outcome Measures
Dobkin (2006, 2007) Multicenter RCT Note: 2006 report includes primary outcomes at 6 months, 2007 report includes secondary outcomes at 3 months N = 146 Mean age: NR Males: NR Inclusion:

  • Ages 16-70 years

  • Traumatic SCI ≤56 days of injury, entered into SCILT

  • Incomplete lesion

  • ≤3 FIM-L score

  • MMSE score ≥26

Exclusion:

  • Contraindications to therapy

  • Disease prior to SCI that causes exercise intolerance/immobility

  • Antispasticity medication

  • Unlikely to complete therapy or return for F/U

  • Mobility training for an average of 1 hour/day for 12 weeks (max 60 sessions)

  • Standard inpatient and outpatient rehabilitation therapy for mobility and self-care skills

Intervention: BWSTT:

  • Step training with body weight support on a treadmill

Control: Overground gait training:

  • Conventional standing and overground mobility training

Mean time from injury to rehabilitation: 4.5 weeks		 ASIA grade: At entry into study:

  • ASIA A (n = 0)

  • ASIA B (n = 43)

  • ASIA C (n = 74)

  • ASIA D (n = 6)

Injury level:

  • C4-T3

  • UMN, n = 111: cervical to T10/T11 lesion

  • LMN, n = 35: T11-L3 lesion

 3 months after initiation of rehabilitation (80.1%) 6 months after initiation of rehabilitation (70.5%)

  • Primary: overground walking speed, FIM-L

  • Secondary: LEMS, walking distance, Berg Balance Scale, WISCI
Harvey (2011) Multicenter RCT N = 32 Median age: 27 (IQR: 24-31) years Males: 93.8% (30/32) Inclusion:

  • Age >18 years

  • Incomplete/complete SCI below T1

  • Sustained SCI <6 months prior

  • Receiving physiotherapy and occupational therapy in a comprehensive inpatient program (Moorong SCI Unit or Centre for Rehabilitation of the Paralyzed)

  • Limited ability to sit unsupporteda

Exclusion:

  • Unlikely to complete therapy

  • Pressure ulcers requiring bed rest

 Intervention: Training unsupported sitting:

  • Additional 30 min task-specific training by a physiotherapist, 3×/week for 6 weeks

  • Practiced specifically designed exercisesb

  • Standard inpatient therapyc (control group)

Control: Standard inpatient therapy c :

  • None of the intervention group exercises

  • Bangladesh site: 5-min sessions of unsupported sitting training, 3×/week for 6 weeks

  • Australian site: no training in unsupported sitting for the duration of the study

Mean time from injury to rehabilitation: 11 weeks		 AIS:

  • AIS A: 90.6% (29/32)

  • AIS B: 6.3% (2/32)

  • AIS C: 3.1% (1/32)

Injury level:

  • T1-T4: 15.6% (5/32)

  • T5-T8: 21.9% (7/32)

  • T9-L1: 62.5% (20/32)

 6-7 weeks (84.4%)

  • Primary: Maximal Lean Test, Maximal Sideward Reach Test, COPM Performance Item

  • Secondary: COPM Satisfaction Item, T-Shirt Test, Participant’s and Clinician’s Impressions of Change, SCI Falls Concern Scale
Kohlmeyer (1996) RCT N = 60 n = 44 Mean age: 38.8 years Males: 90.9% (40/44) Inclusion:

  • Tetraplegia due to traumatic SCI

  • At least a poor grade for anterior deltoid and/or biceps and at least trace in radial wrist extensors

  • Transferred to acute care facility for rehabilitation after a new onset SCI, between 1988 and 1993

Exclusion:

  • Greater than a fair + grade in wrist extensors/the ability to extend wrists against slight resistance

  • Zero strength in wrist extensors

  • Spasticity interfering with function or therapy

 Intervention:

  • Therapy for 5 days/week, for 5-6 weeks

  • 20-min therapy sessions

FES:

  • Conductive carbon rubber electrodes with water-soaked sponges applied over wrist extensors

  • Amplitude adjusted, often to patient tolerance; pulse width 0.3 ms, stimulation frequency 20 Hz, on/off cycle 8 s/8 s, ramp up/down times 2 s

  • Mean time from injury to rehabilitation: 3.2 ± 0.9 weeks

Biofeedback:

  • Observed EMG of wrist extensors in real time on video screen and listened to audio feedback (proportional to strength of contraction)

  • Performed wrist extension following visual patterns and projected on the video screen

  • Mean time from injury to rehabiliation: 2.8 ± 0.8 weeks

FES + biofeedback:

  • Session time divided in half for the 2 modalities

  • Mean time from injury to rehabilitation: 2.5 ± 1.0 weeks

Control: Conventional strengthening therapy:

  • PROM to prevent loss of mobility

  • Orthotic intervention to prevent joint deformity and protect weakened muscles

  • Strengthening of available muscles (light grasp release tasks several times per day for 20-40 min)

  • Involvement of muscles in functional activities

  • Mean time from injury to rehabiliation: 3.0 ± 0.9 weeks

 Severity of injury:

  • Complete SCI: 56.8% (25/44)

  • Incomplete SCI: 43.2% (19/44)

Injury level:

  • C4: 11.4% (5/44)

  • C5: 61.3% (27/44)

  • C6: 27.3% (12/44)

 6 weeks (73.3%)

  • Manual muscle tests (wrist extensors, anterior deltoid, biceps)

  • Function score (self-feeding abilities)
Lucareli (2011) RCT N = 30 n = 24 Mean age: 31.5 years Male: 58.3% (14/24) Inclusion:

  • Ages 23-40 years

  • Reciprocal gait pattern

  • Mild spasticity (score ≤2 on modified Ashworth scale)

  • Medical authorization to participate

Exclusion:

  • Cardiac pacemaker or unstable angina, other decompensated heart disease, COPD, uncontrolled AD, fractures of lower limb bones, deformity/rigidity of hip, knee or ankle joints, or pressure ulcers

  • Attended <85% of sessions

 Therapy for 2 times/week, 30 minutes/session, for 4 months Intervention: BWSTT:

  • Treadmill with body weight supported and conventional physiotherapyd

  • Time from injury to rehabilitation: <12 months

Control: Overground gait training:

  • Conventional physiotherapyd

  • Time from injury to rehabilitation: < 12 months

 ASIA grade e :

  • ASIA C: 45.8% (11/24)

  • ASIA D: 54.2% (13/24)

  • Injury level: C4-L2

 4 months (80%)

  • Spatial-temporal variables (velocity, distance, cadence, step length, swing phase, stance phase and gait cycle duration, angular kinematic parameters)

  • Safety measures NR
Popovic (2011) RCT N = 24 n = 21 Mean age: 43.3 (18-66) years Males: 76.2% (16/21) Inclusion:

  • Inpatient population at the SCI unit at the Toronto Rehabilitation Institute

  • Traumatic incomplete SCI (C4-C7), AIS B, C, or D, <6 months prior to baseline assessment

  • Age ≥18 years

  • Unable to grasp and manipulate various objects either unilaterally or bilaterally

Exclusion:

  • Patients with contraindications for FES

  • Individuals who suffered from cardiovascular contraindications

  • Individuals with denervated muscles

 Therapy for 10 hours/week, for 8 weeks Intervention: FES:

  • 1 hour FES and 1 hour COT daily

  • Electrodes placed on muscles/nerves to stimulate finger flexion/extension, thumb opposition/flexion, wrist flexion/extension

  • Balanced, biphasic, current-regulated electrical pulses, amplitude 8-50 mA, pulse width 250 μs, pulse frequency 40 Hz

  • Conventional occupational therapy (control group)

  • Time from injury to rehabilitation: 69.9 ± 14.11 days

Control: Conventional occupational therapy:

  • 2 hours COT daily

  • Muscle facilitation exercises emphasizing the neurodevelopmental treatment approach

  • Task-specific, repetitive functional training; strengthening/motor control training using resistance; stretching exercises; FES applied for muscle strengthening; training in ADLs

  • Time from injury to rehabiliation: 58.33 ± 6.55 days

 Severity of injury:

  • Complete SCI: 0% (0/21)

  • Incomplete SCI: 100% (21/21)

Injury level:

  • C3-C7: 4.8% (1/21)

  • C4: 33.3% (7/21)

  • C4-C5: 9.5% (2/21)

  • C5: 14.3% (3/21)

  • C5-C6: 9.5% (2/21)

  • C6: 14.3% (3/21)

  • C6-C7: 14.3% (3/21)

 8 weeks (87.5%)

  • FIM Motor score, FIM Self-Care score, SCIM Self-Care, TRI-HFT

Abbreviations: AD, autonomic dysreflexia; ADL, activities of daily living; BWSTT, body weight–supported treadmill training; CI, confidence interval; CoE, class of evidence; COPD, chronic obstructive pulmonary disease; COPM, Canadian Occupational Performance Measure; COT, conventional occupational therapy; EMG, electromyography; ES, electrical stimulation; FES, functional electrical stimulation; FIM, Functional Independence Measure; FIM-L, Functional Independence Measure Locomotor Score; IQR, interquartile range; LEMS, lower extremity motor score; LMN, lower motor neuron; MMSE, Mini-Mental State Examination; MVA, motor vehicle accident; NR, not reported; PROM, passive range of motion; RCT, randomized controlled trial; SCI, spinal cord injury; SCILT, Spinal Cord Injury Locomotor Trial; SCIM, spinal cord independence measure; TBWS, treadmill with body weight support; TRI-HFT, Toronto Rehabilitation Institute–Hand Function Test; UMN, upper motor neuron; WISCI, Walking Index for Spinal Cord Injury.

ASIA grade (Dobkin 2006, 2007; Lucareli 2011): categorizes motor and sensory impairment in patients with SCI; (A) complete—no sensory or motor function is preserved in sacral segments S4-S5; (B) incomplete—sensory, but not motor, function is preserved below the neurologic level and extends through sacral segments S4-S5; (C) incomplete—motor function is preserved below the neurologic level, and most key muscles below the neurologic level have muscle grades less than 3; (D) incomplete—motor function is preserved below the neurologic level, and most key muscles below the neurologic level have muscle grades greater than or equal to 3; (E) normal—sensory and motor functions are normal.

FIM-L scale (Dobkin 2006, 2007): (1) = dependent, total physical assistance; (2) = maximum assistance, one helper to walk 50 feet and patient performs <50% of task; (3) = moderate assistance, one helper to walk 50 feet and patient performs 50%-75% of task; (4) = minimal assistance, one helper to walk at least 50 feet and patient performs >75% of task; (5) = supervision, no contact by helper to walk at least 50 feet; (6) = independent with equipment to walk at least 150 feet in a reasonable time; (7) = independent to walk >150 feet without assistive devices in a reasonable time.

Function score (Kohlmeyer 1996): A score of (0) = unable to perform, (1) = able to perform but not functional, and (2) = able to perform functionally is assigned for each of the following tasks: (1) feeds self without use of wrist support (may use utensil cuff); (2) picks up light finger foods (popcorn, chips); (3) picks up moderate weight finger foods (cookie, half sandwich): (4) picks up and drinks from a 12-oz soda can.

Manual muscle tests (Kohlmeyer 1996): Muscles were graded based on the following scoring system: (0) = no palpation or movement; (1) = palpable (must palpate at least 3 times); (2) = moves less than ½ available range when gravity eliminated; (3) = moves more than ½ available range when gravity eliminated; (4) = moves to neutral against gravity; (5) = moves full range against gravity but takes no resistance; (6) = moves full range against gravity and takes slight resistance; (7) = moves full range against gravity and takes good resistance (can still break); (8) = moves full range against gravity and you cannot break hold; NOT TESTED = used when an extremity was not tested.

SCIM Self-Care Score (Popovic 2011): Includes feeding, bathing, dressing, and grooming, and is scored from 0 to 20.

TRI-HFT (Popovic 2011): Evaluates gross motor function of unilateral grasp, power grasp, lateral pitch, and precision grip, as well as strength of power and lateral grasps. Scored on a scale of 0 to 7: (0) = no movement elicited; that is, the subject is unable to reach for the object; (1) = the subject is able to reach for the object but unable to grasp the object; (2) = the subject is able to reach and grasp (using passive grasp) but unable to lift the object successfully off the supporting surface; (3) = the subject is able to reach and grasp (using active grasp) but unable to lift the object successfully off the supporting surface; (4) = the subject is able to reach, grasp, and lift the object (using passive grasp) but unable to manipulate the object; (5) = the subject is able to reach, grasp, and lift the object (using active grasp) but unable to manipulate the object; (6) = the subject is able to reach, grasp, lift, and manipulate the object (using passive grasp) appropriately; (7) = the subject is able to reach, grasp, lift, and manipulate the object (using active grasp) appropriately.

a Definition of unsupported sitting (Harvey 2011): 5/7 or less on the unsupported sitting item of the Clinical Outcomes Variable Scale, cited in Campbell et al (2003).

b Unsupported sitting therapy consisted of 84 potential exercises involving movement of the upper body over and outside the base of support (with 3 grades of difficulty = 252 exercises). Developed by Boswell-Ruys et al (2010), written on cards and chosen arbitrarily by the patient during each session.

c Standard physiotherapy and occupational therapy which included training for transfers, wheelchair skills, dressing, and showering.

d Conventional physiotherapy consisted of the following: (1) passive stretching for 30 seconds for all muscle groups of the lower limbs, taking around 8 minutes in total, (2) passive mobilization of the hip, knee and ankle joints for 5 minutes, and (3) overground gait training conducted and supervised by a physiotherapist (verbal commands and manual contact for correction of movements). When necessary, the parallel bars were used to ensure the safety of the patient. All of the patient’s weight was placed on the floor, and the upper limbs were used as supports on the parallel bars when necessary.

e There were discrepancies in the initial ASIA scores summarized in the authors' demographic table (Lucareli, 2011).