Wheel Assisted Running Training (WART) in Children With Cerebral Palsy

Cerebral Palsy Clinical Trial

— WART  

Official title:

Wheel Assisted Running Training in Children With Cerebral Palsy: A Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00946439
• Other study ID #: Revital123
• Status: Completed
• Phase: N/A
• First received: July 24, 2009
• Last updated: July 24, 2009
• Start date: September 2004
• Est. completion date: September 2006

Study information

• Verified date: July 2009
• Source: Israel Sport Center for the Disabled
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The purpose is to evaluate the effects of adding a wheel assisted running training (WART) to a conventional mixed physical activity training (CT) program on walking and gross motor function in trained children with cerebral palsy (CP).

Method entails recruiting thirty children with CP (16 females, 14 males), with mean (SD) age 11.8 (3.5) and training experience 3.4 (3.5), years were assigned to either WART or CT groups. The energy Expenditure Index (EEI), the Gross Motor Function Measure 66 (GMFM), self-selected and fast walking velocity (SSV and FV, respectively), and cadence are administered by a trained physical therapist. The intervention period is six months, with two sessions per week.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2006
• Est. primary completion date: September 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 19 Years

Eligibility

Inclusion Criteria:

• (a) medical diagnosis of cerebral palsy;

• (b) ability to comprehend instructions in a group setting;

• (c) no medical procedures involving the lower limbs (including casting and Botox injections) during the last six months prior to pre-testing;

• (d) able to walk three minutes at a self paced speed;

• (e) no seizures during the last year, and (f) functional performance levels between II-IV of the gross motor functional classification system (GMFCS)

Exclusion Criteria:

• (a) GMFCS I or V;

• (b) Not being able to comprehend or comply with instructions.

Study Design

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

Related Conditions & MeSH terms

• Cerebral Palsy

Intervention

Device:
• Wheel assisted running training
'Race-Runner' uses the principle of body weight reduction and wheel assisted running training. This is a three-wheel device specifically designed in the 1990s for athletic purposes. The participant is walking or running with the feet on the ground while using a triangular frame equipped with three large bicycle wheels. Support to the participant's body is provided by a regular cycle saddle, a frontal body support plate, and the steering handlebars. The vertical and horizontal distance of the saddle and frontal support from the steering handlebars are adaptable to the participant's body dimension and comfort. This equipment is commonly used in competition in Scandinavia and Central Europe

Locations

Country	Name	City	State
Israel	Israel Sport Center for the Disabled	Ramat Gan

Sponsors (2)

Lead Sponsor	Collaborator
Israel Sport Center for the Disabled	Tel-Aviv Sourasky Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	walking velocity		six months	No
Secondary	Energy expenditure index		six months	No