NCT00946439

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2004

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2004

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2006

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2006

Completed
2.9 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 27, 2009

Completed
Last Updated

July 27, 2009

Status Verified

July 1, 2009

Enrollment Period

2 years

First QC Date

July 24, 2009

Last Update Submit

July 24, 2009

Conditions

Keywords

training exercise gait

Outcome Measures

Primary Outcomes (1)

  • walking velocity

    six months

Secondary Outcomes (1)

  • Energy expenditure index

    six months

Interventions

'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

Also known as: also called 'Petra'

Eligibility Criteria

Age6 Years - 19 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • (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)

You may not qualify if:

  • (a) GMFCS I or V;
  • (b) Not being able to comprehend or comply with instructions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Israel Sport Center for the Disabled

Ramat Gan, 52535, Israel

Location

MeSH Terms

Conditions

Cerebral Palsy

Condition Hierarchy (Ancestors)

Brain Damage, ChronicBrain DiseasesCentral Nervous System DiseasesNervous System Diseases

Study Officials

  • Yeshayahu Hutzler, Ph.D

    Israel Sport Center for the Disabled

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 24, 2009

First Posted

July 27, 2009

Study Start

September 1, 2004

Primary Completion

September 1, 2006

Study Completion

September 1, 2006

Last Updated

July 27, 2009

Record last verified: 2009-07

Locations