Supported Speed Treadmill Training Exercise Program (SSTTEP) for Marginally Ambulatory Children With Cerebral Palsy — SSTTEP  

Cerebral Palsy Clinical Trial

Official title: Multi-Center Project: Supported Speed Treadmill Training Exercise Program (SSTTEP) for Marginally Ambulatory Children With Cerebral Palsy

Status Active, not recruiting

Clinical Trial Summary

The investigators are studying the effects of a 12-week exercise program, consisting of either:

1. Walking on a treadmill with partial body weight

2. Functional exercise program

The investigators would like to know the effects these two exercise programs have on the quality of life, muscle strength and control, coordination, walking, and functional movement of children with cerebral palsy who are marginal ambulators. This is a randomized control trial with subjects randomly assigned to one of the 2 groups.Subjects in both groups will be seen twice a day for two weeks at our hospital for intervention and parent training, and then participate in a 10 week home-based program. During each subject's two-week clinic-based training, a parent or caregiver is trained in all home program exercises and/or equipment usage. This person must be able to safely perform the exercise program with the child. Each subject will also need to participate in three separate 5-hour long data collection sessions scheduled over the 4 month study period.

Clinical Trial Description

This project proposes to answer the following questions: Is partial body weight supported treadmill gait training (PBWSTT) effective in improving ambulation abilities, neuromuscular impairments, functional mobility, disability, and quality of life in marginally ambulatory children with cerebral palsy.

Specific Aim 1: Assess the effect of a PBWSTT locomotor training intervention on quality of life, treatment expectations, self-efficacy, and activity and participation of children with CP with limited ambulation skills. We hypothesize that in comparison to a control group, after a 12 week locomotor intervention, children with CP (intervention group) with limited ambulation skills will demonstrate greater improvements in scores from common questionnaires compared to the control group.

Specific Aim 2: Assess the effect of a PBWSTT locomotor training intervention on gross motor skills; physical function; biomechanics and coordination dynamics of ambulation; and physical activity in ambulatory children with CP. We hypothesize that in comparison to a control group, after a 12 week PBWSTT locomotor training intervention children with CP with limited ambulation skills will demonstrate greater improvements in functional test scores compared to the control group.

Specific Aim 3: Assess the effect of a PBWSTT locomotor training intervention on measures of body structure and function including: spasticity; muscle strength; and joint-specific motor control. We hypothesize that in comparison to a control group, after a 12 week PBWSTT locomotor training intervention children with CP with limited ambulation skills will demonstrate greater improvements in: muscle strength, spasticity and joint specific motor control compared to the control group.

This is a single blinded, randomized, controlled pre-test/post-test study design. Sixty six ambulatory children between the ages of 6-12 years of age with cerebral palsy will undergo a 12-week training program. Thirty three of these children will undergo a Supported Speed Treadmill Training Exercise Program (SSTTEP), and the remaining 33 children will receive the same amount of conventional physical therapy in the form of a personalized home exercise program and serve as a control group. Three sets of measures will be obtained: A1) at baseline prior to intervention; A2) at the end of the 12-week intervention period; and A3) 4 weeks after the intervention has ended.

The two primary aims of our study are to assess the efficacy of SSTTEP in improving quality of life, functional ambulation, energy expenditure, gross motor skills, and muscle strength and tone; and to assess the efficacy of SSTTEP in improving the coordination of stepping and ambulation in children with CP.

The intervention group will undergo a program of 10 hours of intensive SSTTEP training over a 14 day period. After the initial training, the subjects will participate in a home program of 30 minutes/5 times per week for an additional 10 weeks.

The control group with undergo a personalized exercise program consisting of 10 hours of intensive training over a 14 day period. After the initial training, the subjects will participate in a home program of 30 minutes/5 times per week for an additional 10 weeks. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cerebral Palsy

• NCT number: NCT00467415
• Study type: Interventional
• Source: Shriners Hospitals for Children
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 2007
• Completion date: December 2009