Cerebral StrokeNCT01000168
Treadmill Therapy and Brain Injuries
A study testing Treadmill therapy and conventional walking therapy. in people with Cerebral Stroke and Hemiplegia, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cerebral Stroke, Hemiplegia, Moderate to Severe Functional Impairments
- What is being tested?
- Treadmill therapy and conventional walking therapy.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- Nov 2004to May 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Cerebral stoke
- Hemiplegia
- Primary rehabilitation
- Medical stable
- Wheelchair user
- Dependent of assistance for walking
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Brain Injury, Sunnaas Rehabilitation Hospital
Nesoddtangen, Bjørnemyrveien 11, 1450
About this study
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
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.
Read more
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".
- Being tested
- Treadmill therapy and conventional walking therapy.
- Keywords
- Brain Injury, Rehabilitation, Treadmill therapy
- Medical subject headings
- Stroke, Hemiplegia, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treadmill therapy and conventional walking therapy.Other
Also called Treadmill training with body weight support (TTBWS)., Laufband Therapy, Traditional 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.
| Study group | Role | What they receive |
|---|---|---|
| Treadmill therapy | Experimental | 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. Receives: Other: Treadmill therapy and conventional walking therapy. |
| Conventional walking therapy | Active comparator | 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. Receives: Other: Treadmill therapy and conventional walking therapy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Ambulation Categories. Ten meter walking test. Six minutes walking test. Functional Independence Measure (task 9 shorter transfer and task 13 stairs).
Measured: 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.
Measured: 0, 5 and 10 weeks, * 0 and 10 weeks, **10 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2009 (estimated)
- Study startNov 2004
- Primary completionMay 2009
- Study completionMay 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cerebral StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Bergen
- Investigators
- Liv Inger Strand, Dr. philos, Principal investigator, University of Bergen, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01000168
- Sponsor's protocol ID
- 20624506 (SunHF)
- Status last verified
- Oct 2009
- First submitted
- 21 Oct 2009
- Last updated
- 23 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01000168
- Acronym / sponsor ID
- 20624506 (SunHF)
- Keywords
- Brain Injury, Rehabilitation, Treadmill therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- University of Bergen
- Study start
- Nov 2004
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 22 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treadmill therapy | Experimental | Other: Treadmill therapy and conventional walking 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. |
| Conventional walking therapy | Active comparator | Other: Treadmill therapy and 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Cerebral stoke
- Hemiplegia
- Primary rehabilitation
- Medical stable
- Wheelchair user
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Treadmill therapy and conventional walking therapy.Also: Treadmill training with body weight support (TTBWS)., Laufband Therapy, Traditional walking therapyThe 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 | Conventional walking therapy, Treadmill therapy |
Primary outcome
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.
1 secondary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2009.
- Background: PubMed 16235304Moseley 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Liv Inger Strand, Dr. philos principal investigator
University of Bergen, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treadmill therapy and conventional walking therapy. in people with Cerebral Stroke and Hemiplegia, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01000168, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2009.