Treadmill Therapy and Brain Injuries

Not Applicable

Completed

• Conditions: Cerebral Stroke; Hemiplegia; Moderate to Severe Functional Impairments

• Registration Number: NCT01000168
• Lead Sponsor: Sunnaas Rehabilitation Hospital

Brief Summary

Introduction.

* There is a demand for evidence whether treadmill therapy is more efficient than traditional walking training as an intervention for patients with hemiplegia after cerebral stroke.

Design.

* A randomized controlled trial.

Material.

* Stroke patients with moderate to severe functional deficits referred to inpatient medical rehabilitation.

Method.

* Comparing a treatment group receiving treadmill training with body weight support with a treatment group receiving conventional walking training.

Study aim:

* Investigate whether treadmill therapy is more effective than traditional functional training in restoring walking and transfer in patients with moderate to severe ambulatory deficits after stroke.

Detailed Description

See "Brief Summary".

Study Timeline

• Study Start: 2004-11
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2009-10
• Study First Submitted: 2009-10-21
• Study First Submitted QC: 2009-10-21
• Study First Posted: 2009-10-22
• Last Update Submitted: 2009-10-22
• Last Update Posted: 2009-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Cerebral stoke
• Hemiplegia
• Primary rehabilitation
• Medical stable
• Wheelchair user
• Dependent of assistance for walking
• Dependent of maximum one person for transfer
• No physical impairments that could prevent walking ability from being restored
• Able to participate in the training modalities

Exclusion Criteria

• Medical unstable
• Orthopaedic or other impairments preventing relearning walking
• Cognitive impairments that prevents understanding the study information
• Cognitive or psychological impairments that prevents study collaboration

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Functional Ambulation Categories. Ten meter walking test. Six minutes walking test. Functional Independence Measure (task 9 shorter transfer and task 13 stairs).	0, 5 weeks and 10 weeks.

Secondary Outcome Measures

Name	Time	Method
EU-Walking Index. Time of "Shorter transfer". Time of "Climbing stairs". Performance of climbing stairs. Heart rate registration. * Temporospatial 3D gait data (a sub group analysis). ** Semistructured interview.	0, 5 and 10 weeks, * 0 and 10 weeks, **10 weeks.

Trial Locations

Locations (1)

Department of Brain Injury, Sunnaas Rehabilitation Hospital; 🇳🇴 Nesoddtangen, Bjørnemyrveien 11, Norway