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

Status unconfirmed · Not applicable

Conditions studied: Cerebral Palsy

In brief

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.

Key facts

Study ID

NCT00467415

Run by

Shriners Hospitals for Children

People needed

66

Starts

2007-05-01

Expected to finish

2009-12-01

Last updated by the study team

2009-06-29

Who can join

Age: 6 and older, up to 13. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• A diagnosis of spastic cerebral palsy;
• Impaired ambulation abilities as evidenced by a decreased in gait velocity below 80% of age expected value or gross motor function classification scale (GMFCS) Level III or IV;
• Able to ambulate independently for 8 steps with/without assistive devices to allow for adequate motion analysis data collection;
• Body weight of less than 150 pounds;
• Between the ages of 6 and 13 years;
• Able to follow multiple step commands and to attend to tasks associated with data collection;
• Willingness to travel to one of the three sites for data collection sessions, and 2 weeks of intensive intervention;
• Willingness to commit to home program 30 minutes per session, 5 times week for 10 weeks, as well as adequate space and supervision for treadmill use at home;
• No reported musculoskeletal, cardiovascular or pulmonary conditions that would limit participation in moderate exercise program;
• Minimum of 12 months post surgery including soft tissue releases
• Six months post-Botox injections, significant changes in Baclofen dosing, or casting procedures to the lower extremities;
• Passive range of motion of lower extremity joints: < 30º contracture of hip in extension as measured by the Thomas Test; passive dorsiflexion range of motion to -15º with the knee extended, and knee extension range (90º/90º test) to 70º and <-20º knee extension.
• At least 2 years post- dorsal rhizotomy.

You may not qualify if…

• Children with "mixed" types of CP (i.e. athetosis) or other movement disorders (e.g. ataxia);
• Children receiving intrathecal Baclofen (baclofen pump);

Where it is running

• Shriners Hospital for Children, Shreveport — Shreveport, Louisiana, United States
• Washington University — St Louis, Missouri, United States
• Shriners Hospital for Children, Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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