None listed
Conditions
Brief summary
This study will be the first scientifically rigorous randomised controlled trial comparing the effects of a 9 week treadmill and body weight support training programme compared to walking practice on the walking ability, quality of life and activities of daily living of school aged children with cerebral palsy. The primary aim of this study is to determine if compared to a supervised walking practice programme, a 9 week, twice a week treadmill and body weight support training programme improves the walking ability (walking speed and walking endurance) of school aged children with cerebral palsy and moderate to severe walking difficulty. The secondary aims are to (a) to determine if a 9-week, twice a week treadmill and body weight support training programme improves the quality of life and activities of daily living compared to a supervised walking practice programme for school aged children with cerebral palsy and (b) to determine the safety and acceptance of treadmill and body weight support gait training within the child’s normal school environment. The study hylothesis is: that a 9 week partial body weight supported treadmill training program will improve the walking performance of school aged children with cerebral palsy more than a 9 week overground walking practice program.
Interventions
Experimental group intervention: Children in the experimental group will complete a 9-week, twice a week partial body weight support treadmill training program, conducted within normal school hours. A physiotherapist will oversee the program but all of the sessions will be directly supervised by a trained and experienced therapy assistant. The children will wear their usual footwear during training, including any orthoses. At each session, the child will be fitted with the appropriate harness,
Experimental group intervention: Children in the experimental group will complete a 9-week, twice a week partial body weight support treadmill training program, conducted within normal school hours. A physiotherapist will oversee the program but all of the sessions will be directly supervised by a trained and experienced therapy assistant. The children will wear their usual footwear during training, including any orthoses. At each session, the child will be fitted with the appropriate harness, and then assisted into the partial body weight support apparatus, which will be placed over the treadmill. A large mirror will be positioned in front of the treadmill to provide the child with feedback on postural alignment and to assist motivation. The child will be asked to stand as upright as possible, and the body weight support will be reduced until the child either begins to flex at the hips or knees, or sit in the harness. The treadmill will be started at the lowest speed (0.2kph) and the speed will be gradually increased in 0.1kph increments to a speed where the child is able to step forward comfortably. If required, the trainer will provide assistance to initiate weight shift or to initiate the swing phase of the gait cycle. Similarly if the child can not independently achieve heel strike, the trainer will manually guided the foot to approximate better heel strike. Each session will go for a maximum of 30 minutes. However, the session will finish earlier if the child indicated they want to stop, or if the child stops stepping forward. The trainer will keep a logbook for each child to record the number of sessions attended, the speed of the treadmill during each training session, and the amount of time and distance walked during each session.
Sponsors
La trobe University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used)
Eligibility
Sex/Gender
All
Age
5 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
(1) have a diagnosis of cerebral palsy, (2) have a functional disability categorized as III or IV on the Gross Motor Function Classification System (GMFCS), and, (3) be able to understand simple instructions, and be able to indicate a desire to cease walking on the treadmill by verbal, gestural, physical or other augmentative means of communication.
Exclusion criteria
1) need physical assistance from another person to walk, or 2) if they have a concurrent medical condition such as severe cardiorespiratory disease or uncontrolled epilepsy that would limit their ability to participate in a treadmill training program; 3) had lower limb orthopaedic surgery, botulinum toxin injections or serial casting in the six months before the trial started.Both male and female participnats will be recruited.
Outcome results
None listed