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. 2017 Jun 11;2017(6):CD011660. doi: 10.1002/14651858.CD011660.pub2

Liao 2007.

Methods Design: randomised controlled trial
Country of origin: Taiwan
Intervention(s): resistance training (loaded sit‐to‐stand exercise)
Unit of allocation: individual
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
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.
Outcomes Assessment time points: baseline (week 0) and postintervention (week 6)
Primary outcome: no primary outcome measure stated
Outcomes:
  1. Gross motor function was assessed using dimensions D and E of the GMFM‐88. The scores on the 2 dimensions, presented as a percentage of total possible points, were averaged. Possible range 0‐100. Higher score indicates better gross motor function

  2. Self‐selected gait speed was calculated using the time it took participants to walk 10 m. The average of 3 trials was used in analysis. Reported in m/min.

  3. Muscle strength was assessed using the 1 RM of the loaded sit‐to‐stand, defined as the maximal load the participant can carry while standing up one time. Reported in kg.

  4. Knee extensor muscle strength was measured using a hand‐held dynamometer. Each leg was assessed 3 times and the average torque of 3 separate trials of both legs was used in data analysis. Reported in kg.

  5. Gait efficiency was measured using the physiologic cost index, calculated as the difference between the resting heart rate and walking heart rate, divided by walking speed. The higher the physiologic cost index the higher the energy consumption during walking.

Notes Source of funding: grant from the National Science Council, Taiwan
Potential conflicts of interest: authors report no conflict of interest; none perceived
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