Treadmill Therapy and Brain Injuries

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

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.

Study Overview

• Status: Completed
• Conditions: Hemiplegia; Cerebral Stroke; Moderate to Severe Functional Impairments
• Intervention / Treatment: Other: Treadmill therapy and conventional walking therapy.

Detailed Description

See "Brief Summary".

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Bjørnemyrveien 11
    • Nesoddtangen, Bjørnemyrveien 11, Norway, 1450
      • Department of Brain Injury, Sunnaas Rehabilitation Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Treadmill therapy; Patients assigned to the "Treadmill therapy group" received daily 30 minutes specific walking training on "treadmill with body weight support" alternatively overground, and 30 minutes functional training, treated by a physiotherapist.	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.; Other Names: Treadmill training with body weight support (TTBWS).; Laufband Therapy; Traditional walking therapy
ACTIVE_COMPARATOR: Conventional walking therapy; Patients assigned to the comparative conventional walking therapy group received daily 30 minutes specific traditional walking training overground and 30 minutes functional training, treated by a physiotherapist.	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.; Other Names: Treadmill training with body weight support (TTBWS).; Laufband Therapy; Traditional walking therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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.

Collaborators and Investigators

• Sponsor: Sunnaas Rehabilitation Hospital
• Collaborators: University of Bergen
• Investigators: Principal Investigator: Liv Inger Strand, Dr. philos, University of Bergen, Norway

Publications and helpful links

General Publications

• 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. doi: 10.1002/14651858.CD002840.pub2.

Study record dates

Study Major Dates

• Study Start: November 1, 2004
• Primary Completion (ACTUAL): May 1, 2009
• Study Completion (ACTUAL): May 1, 2009

Study Registration Dates

• First Submitted: October 21, 2009
• First Submitted That Met QC Criteria: October 21, 2009
• First Posted (ESTIMATE): October 22, 2009

Study Record Updates

• Last Update Posted (ESTIMATE): October 23, 2009
• Last Update Submitted That Met QC Criteria: October 22, 2009
• Last Verified: October 1, 2009

More Information

Terms related to this study

• Keywords: Rehabilitation; Brain Injury; Treadmill therapy
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Paralysis; Stroke; Hemiplegia
• Other Study ID Numbers: 20624506 (SunHF)