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

NCT00467415 | Unknown

• 1 other identifier: SHC_COSAB9147
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 3

Brief Summary

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

1. 1.Walking on a treadmill with partial body weight
2. 2.Functional exercise program

Conditions

Cerebral Palsy

Keywords

Walking; Treadmill; Partial Weightbearing

Outcome Measures

Primary Outcomes (9)

• Gait Spatio-Temporal Parameters

  6 months

• Muscle Activation and Timing

  6 months

• Pediatric Quality of Life Inventory (PEDS-QL)

  6 months

• Canadian Occupational Performance Measure (COPM)

  6 months

• Children's Assessment of Participation and Enjoyment (CAPE)

  6 months

• Piers-Harris Children's Self-Concept Scale, 2nd Edition (PHCSCS-2)

  6 months

• Gross Motor Function Measure (GMFM)

  6 months

• Pediatric Outcomes Data Collection Instrument (PODCI)

  6 months

• Gait Velocity

  6 months

Interventions

Partial body weight support treadmill training BEHAVIORAL

Treadmill ambulation for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week.

Exercise BEHAVIORAL

Functional Strengthening exercise program for 12 weeks. First 2 weeks for 10 total dose hours within clinical setting, final 10 weeks with 30 min/5 times week.

Eligibility Criteria

• Age: 6 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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);

Sponsors & Collaborators

• Shriners Hospitals for Children: lead

Study Sites (3)

Shriners Hospital for Children, Shreveport

Shreveport, Louisiana, 71103, United States

Location

Washington University

St Louis, Missouri, 63104, United States

Location

Shriners Hospital for Children, Philadelphia

Philadelphia, Pennsylvania, 19140, United States

Location

MeSH Terms

Conditions

Cerebral Palsy

Interventions

Exercise

Condition Hierarchy (Ancestors)

Brain Damage, Chronic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Randal Betz, MD

  Shriners Hospital for Children, Philadelphia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 27, 2007
• First Posted: April 30, 2007
• Study Start: May 1, 2007
• Primary Completion: October 1, 2009
• Study Completion: December 1, 2009
• Last Updated: June 29, 2009

Record last verified: 2008-08

Locations

US (3)