StrokeNCT00844870
Exploring New Approaches in Reaching Behavior Post Stroke
A study testing stabilization training and auditory training group in people with Stroke, run by University of the Sciences in Philadelphia.
Trial summary
After 4 weeks of training the hypothesis that the more natural training program would yield greater functional changes was proven correct. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Stroke
- What is being tested?
- stabilization training and auditory training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Apr 2007to Sep 2008
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Individuals all scored between 20 and 44 on the Upper-Arm subsection of the Fugl-Meyer Scale (FM- Poole \& Whitney, 1988) and demonstrated some trunk movement during the pretest reaching performance scale measures (RPS, Levin 2006)
Who cannot join
- Individuals were referred if they had no receptive aphasia, apraxia or other cognitive deficits.
About this study
Official title: Training With or Without Upper Body Restraint During Reaching in Individuals Post Stroke
After 4 weeks of training the hypothesis that the more natural training program would yield greater functional changes was proven correct.
Read the detailed description
Analysis indicated that both methods improved reaching without trunk use Reaching performance scale (RPS), but the trunk -stabilized group led to more significant changes. Training under less restrictive conditions associated with Task-Related Training (TRT) (auditory feedback from trunk sensor) as compared to stabilized TRT, led to improved functional and impairment measure scores (WMFT, FM and shoulder flexion). Conclusion: Fading feedback with both training methods, during extended TRT reaching/grasping practice generally led to some improvements. However, as demonstrated by impairment and functional outcome measures, using TRT with an auditory feedback signals is a more effective approach than forcing the stabilization of the trunk during rehabilitation of the upper-limb.
- Conditions
- Stroke
- Being tested
- stabilization training, auditory training group
- Keywords
- rehabilitation, reaching, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stabilization trainingBehavioural
training of arm function with the trunk stabilized
auditory training groupBehavioural
response to an auditory signal
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | stabilization training group Receives: Behavioral: stabilization training |
| 2 | Experimental | auditory response training group Receives: Behavioral: auditory training group |
What is being measured
The primary outcome is the main question the study is designed to answer.
WMFT
Measured: 1 year
Secondary outcomes (1)
FM and shoulder flexion
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2009 (estimated)
- Study startApr 2007
- Primary completionAug 2008
- Study completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of the Sciences in Philadelphia
- Sponsor type
- University, hospital or other
- Investigators
- Gregory T Thielman, Ed.D, Principal investigator, University of the Sciences in Philadelphia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00844870
- Sponsor's protocol ID
- 06-007
- Status last verified
- Feb 2009
- First submitted
- 13 Feb 2009
- Last updated
- 16 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training With or Without Upper Body Restraint During Reaching in Individuals Post Stroke
- ClinicalTrials.gov ID
- NCT00844870
- Acronym / sponsor ID
- 06-007
- Conditions
- Stroke
- Keywords
- rehabilitation, reaching, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of the Sciences in PhiladelphiaUniversity, hospital or other
- Study start
- Apr 2007
- Primary completion
- Aug 2008 (actual)
- Study completion
- Sep 2008 (actual)
- First posted
- 16 Feb 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.
After 4 weeks of training the hypothesis that the more natural training program would yield greater functional changes was proven correct.
Detailed description
Analysis indicated that both methods improved reaching without trunk use Reaching performance scale (RPS), but the trunk -stabilized group led to more significant changes. Training under less restrictive conditions associated with Task-Related Training (TRT) (auditory feedback from trunk sensor) as compared to stabilized TRT, led to improved functional and impairment measure scores (WMFT, FM and shoulder flexion). Conclusion: Fading feedback with both training methods, during extended TRT reaching/grasping practice generally led to some improvements. However, as demonstrated by impairment and functional outcome measures, using TRT with an auditory feedback signals is a more effective approach than forcing the stabilization of the trunk during rehabilitation of the upper-limb.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: stabilization trainingstabilization training group |
| 2 | Experimental | Behavioral: auditory training groupauditory response training group |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals all scored between 20 and 44 on the Upper-Arm subsection of the Fugl-Meyer Scale (FM- Poole \& Whitney, 1988) and demonstrated some trunk movement during the pretest reaching performance scale measures (RPS, Levin 2006)
Key exclusion criteria (1 listed)
- Individuals were referred if they had no receptive aphasia, apraxia or other cognitive deficits.
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 |
|---|---|---|
| stabilization trainingtraining of arm function with the trunk stabilized | Behavioural | 1 |
| auditory training groupresponse to an auditory signal | Behavioural | 2 |
Primary outcome
WMFT
Time frame: 1 year
1 secondary outcome
FM and shoulder flexion
Time frame: 1 year
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 16 Feb 2009.
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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.
Gregory T Thielman, Ed.D principal investigator
University of the Sciences in Philadelphia
Questions about this trial
What is this clinical trial studying?
A study testing stabilization training and auditory training group in people with Stroke, run by University of the Sciences in Philadelphia.
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 1 inclusion and 1 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 16 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
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?
WMFT (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Feb 2009.