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CompletedNCT01000168Updated Oct 23, 2009

Treadmill Therapy and Brain Injuries

An interventional study of Treadmill therapy and conventional walking therapy. in Cerebral Stroke, Hemiplegia and Moderate to Severe Functional Impairments, sponsored by Sunnaas Rehabilitation Hospital. Completed at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-23.

Sponsored by Sunnaas Rehabilitation Hospital · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
Read the detailed description

See "Brief Summary".

02

Conditions studied

  • Cerebral Stroke
  • Hemiplegia
  • Moderate to Severe Functional Impairments

Keywords

  • Brain Injury
  • Rehabilitation
  • Treadmill therapy
03

In context

Stroke

7,286 studies on the registry are indexed under Stroke; 2,007 are open to participants now.

This study's enrollment of 60 is above the median of 50 across 5,369 interventional studies indexed under Stroke.

Browse Stroke studies →

Lead sponsor

Sunnaas Rehabilitation Hospital is the lead sponsor of 24 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Investigator)
Enrollment
60 participants (actual)

Study arms

  • 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.

  • 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.

Interventions

  • OtherTreadmill 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.

    Also known as: Treadmill training with body weight support (TTBWS)., Laufband Therapy, Traditional walking therapy

06

What researchers measure

Primary outcomes

  1. Functional Ambulation Categories. Ten meter walking test. Six minutes walking test. Functional Independence Measure (task 9 shorter transfer and task 13 stairs).

    Time frame: 0, 5 weeks and 10 weeks.

Secondary outcomes

  1. 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.

    Time frame: 0, 5 and 10 weeks, * 0 and 10 weeks, **10 weeks.

07

Study locations

1 site
  • Department of Brain Injury, Sunnaas Rehabilitation Hospital
    Nesoddtangen, Bjørnemyrveien 11 1450, Norway
08

References and documents

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. PubMed 16235304 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01000168
Lead sponsor
Sunnaas Rehabilitation Hospital
Collaborators
University of Bergen
First posted
Oct 22, 2009
Start date
Nov 2004
Primary completion
May 2009
Completion
May 2009
Last update
Oct 23, 2009

Study contacts

Liv Inger Strand, Dr. philos
principal investigator · University of Bergen, Norway

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2009. You cannot join it, but the record below documents what was studied.

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