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Cerebrovascular AccidentPhase 2NCT00037908

Effects of Strength Training on Upper-Limb Function in Post-Stroke Hemiparesis

A Phase 2 study testing Strength training in people with Cerebrovascular Accident and Hemiparesis, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Our overall goal is to develop therapeutic interventions to improve upper-limb motor function in hemiparetic persons based on an improved understanding of the mechanisms responsible for its loss and recovery. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Cerebrovascular Accident, Hemiparesis
What is being tested?
Strength training
Type of treatment
Surgery or procedure
How many people
60 participants
Where
1 siteUnited States
Study dates
Oct 2000to Sep 2003
Phase
Phase 2
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

Post stroke

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VAMC

    Palo Alto, California

Other trials in United States

About this study

Our overall goal is to develop therapeutic interventions to improve upper-limb motor function in hemiparetic persons based on an improved understanding of the mechanisms responsible for its loss and recovery. We intend to rigorously evaluate the efficacy of these interventions with clinical trials, and to study the mechanisms by which these interventions affect motor recovery. In this proposal, we will use a controlled, randomized, double blind clinical trial to study the effects of shoulder and elbow strength training in subjects in the subacute phase of recovery following stroke.

Read the detailed description

Hypotheses: The specific hypotheses that we will test in this proposal all refer to persons with post-stroke hemiparesis in the subacute phase of recovery (completed all out-patient therapy programs, but still less than 6 months post-CVA).

  1. a) Standard functional rehabilitation combined with strength training in the form of high-intensity resistance exercise results in greater gains in elbow and shoulder strength than standard functional rehabilitation alone.
  2. This increased strength is not accompanied by increased hypertonia. c) This increased strength is not accompanied by significant muscular hypertrophy.
  3. Standard functional rehabilitation combined with strength training results in greater improvements in motor function than functional rehabilitation alone.
  4. Strength training results in improved control of elbow trajectory tracking movements and shoulder-elbow reaching movements.

Specific Objectives

  1. To perform a controlled, randomized, double-blind clinical trial to test the effects of high-intensity resistance exercise at the shoulder and elbow. Two interventions will be compared: standard functional rehabilitation (SFR), and standard functional rehabilitation combined with high-intensity resistance exercise (strength training) (SFR+STR). We will study persons with post-stroke hemiparesis in the subacute phase of recovery, i.e. having completed all outpatient therapy programs, but still less than 6 months post-CVA. Outcome measures will include strength (maximal voluntary isovelocity joint torque), hypertonia (onset threshold of the stretch reflex, Modified Ashworth Scale), standard clinical assessment of activities of daily living (Barthel Index, Functional Independence Measure), and upper extremity motor function (Fugl-Meyer exam, Functional Test of the Hemiparetic Upper Extremity).
  2. To study the neuromuscular mechanisms associated with improvements in strength and motor control that result from these interventions. Strength changes will be investigated by measuring muscle hypertrophy, hyperreflexia, and passive stiffness. Changes in control of upper extremity movements will be investigated by measuring motor performance and muscle activation patterns in trajectory tracking and reaching tasks.

Our long term goal is to develop therapeutic interventions to improve upper-limb motor function in persons with post-stroke hemiparesis. Improved motor function involves not only increased strength at the shoulder and elbow, but also increased strength and dexterity at the wrist and hand. The proposed study will establish a foundation by demonstrating the positive effects of strength training in persons with hemiparesis. Then, in future studies, we can investigate the effects of specific interventions at the hand and wrist and investigate physiologic mechanisms subserving change in neuromuscular function following strength training.

Being tested
Strength training
Keywords
Stroke, Hemiparesis, Upper limb function, Strength training
Medical subject headings
Stroke, Paresis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Strength trainingProcedure or surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 May 2002 (estimated)
  2. Study startOct 2000
  3. Study completionSep 2003

Resources

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 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
Double blind
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00037908
Sponsor's protocol ID
B2405R
Status last verified
May 2002
First submitted
24 May 2002
Last updated
21 Jan 2009
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Strength training in people with Cerebrovascular Accident and Hemiparesis, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

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 21 Jan 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 United States. 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.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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.

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 21 Jan 2009.

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