Liao 2007.
Methods |
Design: randomised controlled trial Country of origin: Taiwan Intervention(s): resistance training (loaded sit‐to‐stand exercise) Unit of allocation: individual |
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Participants |
Number of participants: 24 randomised, 20 analysed. Exercise group: n = 10; control group: n = 10; Baseline characteristics provided for n = 20 analysed participants Age: exercise group: mean (SD) = 85.6 (20.8) months; control group: mean (SD) = 91.3 (17.5) months. Sex (male/female): 12/8; exercise group: 7/3; control group: 5/5 Ethnicity: not stated GMFCS level: level I (n = 10), level II (n = 10); exercise group: level I (n = 4) and level II (n = 6); control group: level I (n = 6) and level II (n = 4) Type of motor abnormality: spastic CP Anatomical distribution of CP: diplegia Inclusion criteria: aged 5‐12 years, spastic diplegia, GMFCS level I or II, able to stand up from a chair independently and maintain standing for more than 5 seconds, able to follow verbal instructions, without obvious limitation in passive range of motion of the lower limbs, able to attend physiotherapy at least once a week before and during the study, not received strength training in last 3 months, parental commitment to allow participation without altering current therapy or activity Exclusion criteria: orthopaedic intervention, selective dorsal rhizotomy or botulinum toxin injection to the lower extremities within 6 months, or orthopaedic problems or medical conditions that prevented participants from participating in the exercises |
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Interventions |
Aim of the intervention: to increase muscle strength Type of exercise programme: resistance training Exercise mode: loaded sit‐to‐stand exercise with weighted vest Comparator: all participants in both groups performed their regular physiotherapy programme which included passive range‐of‐motion exercises, positioning, balance training, functional training, and neurodevelopment training. At the start of the study both groups had 2 participants per group who had physiotherapy twice a week and 8 participants per group who received physiotherapy once a week. During a SARS epidemic participants in both groups decreased or stopped physiotherapy. In the control group, 1 participant received physiotherapy 2 days per week, 5 participants received physiotherapy 1 day per week, 1 participant received physiotherapy once every 2 weeks, and 3 participants didn't receive any physiotherapy. In the exercise group, 4 participants received physiotherapy 1 day per week, 2 participants received physiotherapy once every 2 weeks, and 4 participants discontinued physiotherapy Setting: home‐based programme Intervention provider: trainer taught participants and their caregivers how to perform the exercise and modify the exercise during a visit to the home or study site, every other week. Exercises at home supervised by caregiver Duration of programme: 6 weeks Exercise dose: 3 sets of sit‐to‐stand exercises; 2 sets of 10 repetitions at 20% of 1 repetition maximum (RM), 1 set performing as many repetitions as possible at 50% 1 RM until fatigue. 3 times per week Tailoring of intervention to individual: resistance applied was progressively increased to ensure the participant was performing exercises at 50% of 1 RM every 2 weeks Fidelity to prescribed intervention: trainer insured the compliance of exercises during the training period via telephone interview. An exercise diary was provided to the caregiver to document the participant's exercise date, weight and number of repetitions in each exercise session. Participants in the experimental group performed the loaded sit‐to‐stand exercise mean (SD) 18.0 (3.2) times (range 12 to 21 times) during the 6‐week period. All participants performed exercises at least twice a week and 3 participants performed exercises more than 3 times. Participants' average maximum repetitions of 50% of 1 RM sit‐to‐stand varied from 20 to 100 each session. Monitoring of adverse events: most participants in the exercise group reported pressure on the shoulders from the body vest during the loaded sit‐to‐stand. No pain or injury due to training was reported. |
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Outcomes |
Assessment time points: baseline (week 0) and postintervention (week 6) Primary outcome: no primary outcome measure stated Outcomes:
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Notes |
Source of funding: grant from the National Science Council, Taiwan Potential conflicts of interest: authors report no conflict of interest; none perceived |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk |
Quote: "[r]andomised block design" Comment: insufficient information regarding the method of sequence allocation was provided to make a judgement |
Allocation concealment (selection bias) | Unclear risk | Comment: insufficient information regarding allocation concealment was provided to make a judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: given the nature of the intervention participants were not blinded to treatment allocation |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "[o]ne blinded tester (Y‐CL) who is a physical therapist with pediatric assessment experience (including GMFM‐88, gait speed) for 6 years, conducted the outcome measures and demographic data collection." |
Incomplete outcome data (attrition bias) All outcomes | Unclear risk |
Quote: "[o]f 24 children, 4 children (2 in experimental group, 2 in control group) withdrew before the study's completion because parents were concerned about SARS and did not want their children to come to the laboratory, which was located inside a hospital, for a follow‐up test" Quote: "Some of the demographic data of these children who withdrew differed from the participant children. Compared with the participant children, the children who withdrew were statistically significantly older (109.8±6.4mo), heavier (26.1±4.3kg), and taller (127.0±10.9cm). However, their outcome measure data for the pre‐assessment were similar to the participant children in this study." Comment: attrition accounted for but high level of missing data (17%). Missing data evenly distributed across groups and no reported differences in baseline data between groups. |
Selective reporting (reporting bias) | Unclear risk | Comment: a protocol is not available for this study and therefore unable to determine if all expected outcomes are reported. No convincing text provided to indicate that published report includes all expected outcomes |
Other bias | Unclear risk | Comment: baseline outcome and demographic data only includes those who completed the trial |