StrokeNCT00222339
Task-Related Training of Arm Use After Stroke
A study testing task-specific training in people with Stroke, run by University of Melbourne at 1 site in Australia.
Trial summary
Stroke is the leading cause of long-term physical disability in Australia. Currently around 25% of hemiplegic stroke patients discharged from rehabilitation have significantly impaired use of the affected hand with consequent dependence in dressing, grooming and feeding themselves. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke
- What is being tested?
- task-specific training
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 30 participants
- Where
- 1 siteAustralia
- Study dates
- Feb 2002to Jun 2004
- 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
- within 6 weeks of first stroke
- unilateral stroke
- impaired arm function
- able to cope with intensive training program
- medically stable
- able to understand instructions
Who cannot join
- uncontrolled systemic disease
- significant musculotendinous or bony restrictions of the affected upper limb
- any serious chronic disease independently causing significant disability of the affected limb
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Task-Related Training of Arm Use After Stroke: a Randomised Controlled Trial
Stroke is the leading cause of long-term physical disability in Australia. Currently around 25% of hemiplegic stroke patients discharged from rehabilitation have significantly impaired use of the affected hand with consequent dependence in dressing, grooming and feeding themselves. The poor outcome can be attributed in part to a lack of focus by therapists on the negative signs of stroke (weakness and lack of dexterity) as well as too little time (around 10 minutes per day) being devoted to retraining of the arm. Presently there is a very limited evidence base to guide the content of clinical practice. Results from both animal and human studies suggest that specific post-lesion training can result in substantial improvement in function. The hypothesis is that task-specific training of the affected upper limb to subjects in the early period following stroke will result in significantly better functional outcome than standard intervention.
Read the detailed description
Stroke is the leading cause of long-term physical disability in Australia. Currently around 25% of hemiplegic stroke patients discharged from rehabilitation have significantly impaired use of the affected hand with consequent dependence in dressing, grooming and feeding themselves. The poor outcome can be attributed in part to a lack of focus by therapists on the negative signs of stroke (weakness and lack of dexterity) as well as too little time (around 10 minutes per day) being devoted to retraining of the arm. Presently there is a very limited evidence base to guide the content of clinical practice. Results from both animal and human studies suggest that specific post-lesion training modulates physiological changes that take place in undamaged tissue. It is probable that this training induces use-dependent patterns of neural activity that can selectively drive the reorganization of the undamaged cortical areas and thereby improve the functional outcome for the arm and hand. We have developed a task-specific training program for the upper limb that is unique in a) the focus on performance of functional tasks, and b) the intensity of practice, with patients practising the tasks both during and outside of therapy sessions.
Comparisons: A 3-week daily task-specific training of the affected upper limb compared to a control intervention that does not involve upper limb training. Both interventions are additional to the standard rehabilitation program.
Outcomes measured pre- and post-intervention and 3 months follow-up. Outcome measures include: variables grip and pinch force, dexterity, arm use and quality of life. Severity of stroke, classified according to the upper arm sub-test of the Motor Assessment Scale, will be used as a covariate.
- Conditions
- Stroke
- Being tested
- task-specific training
- Keywords
- Stroke, Hand function, Task-specific training
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
task-specific trainingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Arm and hand function measured using the Motor Assessment Scale and the Chedoke-McMaster Impairment Inventory.
Grip and pinch strength measured using dynamometers.
Secondary outcomes (3)
Dexterity measured using the NK Dexterity Board
Quality of Life measured using the Stroke-adapted Sickness Impact Profile.
Sensation using a validated assessment of tactile spatial resolution.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startFeb 2002
- Study completionJun 2004
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 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
- Enrolment
- 30 participants
Sponsor and investigators
- Lead sponsor
- University of Melbourne
- Sponsor type
- University, hospital or other
- Investigators
- Mary P Galea, PhD, Principal investigator, University of Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00222339
- Sponsor's protocol ID
- H2001/01313
- Status last verified
- Dec 2001
- First submitted
- 13 Sep 2005
- Last updated
- 22 Sep 2005
- Results posted
- No
Publications
Miller K, Galea M, Kilbreath S, Phillips B (2002) Early intensive task-specific sensory and motor training of the upper limb following acute stroke: a pilot study. In Battistin L, Dam M, Tonin P(eds) Neurological Rehabilitation. Bologna:Mondizzi Editore.
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Task-Related Training of Arm Use After Stroke: a Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT00222339
- Acronym / sponsor ID
- H2001/01313
- Conditions
- Stroke
- Keywords
- Stroke, Hand function, Task-specific training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants
- Lead sponsor
- University of MelbourneUniversity, hospital or other
- Study start
- Feb 2002
- Study completion
- Jun 2004
- First posted
- 22 Sep 2005 (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.
Stroke is the leading cause of long-term physical disability in Australia. Currently around 25% of hemiplegic stroke patients discharged from rehabilitation have significantly impaired use of the affected hand with consequent dependence in dressing, grooming and feeding themselves. The poor outcome can be attributed in part to a lack of focus by therapists on the negative signs of stroke (weakness and lack of dexterity) as well as too little time (around 10 minutes per day) being devoted to retraining of the arm. Presently there is a very limited evidence base to guide the content of clinical practice. Results from both animal and human studies suggest that specific post-lesion training can result in substantial improvement in function. The hypothesis is that task-specific training of the affected upper limb to subjects in the early period following stroke will result in significantly better functional outcome than standard intervention.
Detailed description
Stroke is the leading cause of long-term physical disability in Australia. Currently around 25% of hemiplegic stroke patients discharged from rehabilitation have significantly impaired use of the affected hand with consequent dependence in dressing, grooming and feeding themselves. The poor outcome can be attributed in part to a lack of focus by therapists on the negative signs of stroke (weakness and lack of dexterity) as well as too little time (around 10 minutes per day) being devoted to retraining of the arm. Presently there is a very limited evidence base to guide the content of clinical practice. Results from both animal and human studies suggest that specific post-lesion training modulates physiological changes that take place in undamaged tissue. It is probable that this training induces use-dependent patterns of neural activity that can selectively drive the reorganization of the undamaged cortical areas and thereby improve the functional outcome for the arm and hand. We have developed a task-specific training program for the upper limb that is unique in a) the focus on performance of functional tasks, and b) the intensity of practice, with patients practising the tasks both during and outside of therapy sessions.
Comparisons: A 3-week daily task-specific training of the affected upper limb compared to a control intervention that does not involve upper limb training. Both interventions are additional to the standard rehabilitation program.
Outcomes measured pre- and post-intervention and 3 months follow-up. Outcome measures include: variables grip and pinch force, dexterity, arm use and quality of life. Severity of stroke, classified according to the upper arm sub-test of the Motor Assessment Scale, will be used as a covariate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- within 6 weeks of first stroke
- unilateral stroke
- impaired arm function
- able to cope with intensive training program
- medically stable
Key exclusion criteria (3 listed)
- uncontrolled systemic disease
- significant musculotendinous or bony restrictions of the affected upper limb
- any serious chronic disease independently causing significant disability of the affected limb
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 |
|---|---|---|
| task-specific training | Behavioural | – |
Primary outcome
Arm and hand function measured using the Motor Assessment Scale and the Chedoke-McMaster Impairment Inventory.
Grip and pinch strength measured using dynamometers.
3 secondary outcomes
Dexterity measured using the NK Dexterity Board
Quality of Life measured using the Stroke-adapted Sickness Impact Profile.
Sensation using a validated assessment of tactile spatial resolution.
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 22 Sep 2005.
- Results publicationMiller K, Galea M, Kilbreath S, Phillips B (2002) Early intensive task-specific sensory and motor training of the upper limb following acute stroke: a pilot study. In Battistin L, Dam M, Tonin P(eds) Neurological Rehabilitation. Bologna:Mondizzi Editore.
Related trials for Stroke
Not yet recruiting
Temporal Interference Stimulation for Upper-Limb Motor Recovery in Early Subacute Stroke
Acute Ischemic Stroke
RecruitingObservational study
ELATE Study: Evaluating Large-vessel Acute Thrombectomy in Extended Time Window
Acute Ichemic Stroke
Recruiting
Web-Based Tele-Rehabilitation Using Action Observation and Mirror Therapy for Subacute Stroke: A Randomized Controlled Trial
Stroke, Upper Extremity Paresis
Recruiting
Early Motor-Cognitive Integrative Training on Cognitive and Motor Performance in Patients With Aneurysmal Subarachnoid Hemorrhage
Subarachnoid Aneurysm Hemorrhage
Not yet recruiting
Selective Intra-Arterial Hypothermia After Endovascular Treatment for Acute Basilar Artery Occlusion
Acute Ischemic Stroke, Basilar Artery Occlusion
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.
Mary P Galea, PhD principal investigator
University of Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing task-specific training in people with Stroke, run by University of Melbourne at 1 site in Australia.
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 6 inclusion and 3 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 22 Sep 2005. 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 Australia. 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?
Arm and hand function measured using the Motor Assessment Scale and the Chedoke-McMaster Impairment Inventory.. The study lists 2 primary outcomes in all. 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 NCT00222339, 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 22 Sep 2005.