Treadmill Therapy and Brain Injuries

Hemiplegia Clinical Trial

Official title:

The Effect of Treadmill Therapy With Body Weight Support on Walking and Transfer in Patients With Moderate to Severe Ambulatory Deficits After Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01000168
• Other study ID #: 20624506 (SunHF)
• Status: Completed
• Phase: N/A
• First received: October 21, 2009
• Last updated: October 22, 2009
• Start date: November 2004
• Est. completion date: May 2009

Study information

• Verified date: October 2009
• Source: Sunnaas Rehabilitation Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
• Study type: Interventional

Clinical Trial 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.

Description:

See "Brief Summary".

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Cerebral Stroke
• Hemiplegia
• Moderate to Severe Functional Impairments
• Stroke

Intervention

Other:
• Treadmill therapy and conventional walking therapy.
The experimental group received 30 sessions of treadmill therapy with body weight support for a time period of 10 weeks. The conventional group received traditional walking therapy for the same time period.

Locations

Country	Name	City	State
Norway	Department of Brain Injury, Sunnaas Rehabilitation Hospital	Nesoddtangen	Bjørnemyrveien 11

Sponsors (2)

Lead Sponsor	Collaborator
Sunnaas Rehabilitation Hospital	University of Bergen

Country where clinical trial is conducted

Norway, 

References & Publications (1)

Moseley AM, Stark A, Cameron ID, Pollock A. Treadmill training and body weight support for walking after stroke. Cochrane Database Syst Rev. 2005 Oct 19;(4):CD002840. Review. Update in: Cochrane Database Syst Rev. 2014;1:CD002840. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No