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Arm Training in Standing After Stroke

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ClinicalTrials.gov Identifier: NCT04050150
Recruitment Status : Recruiting
First Posted : August 8, 2019
Last Update Posted : August 8, 2019
Sponsor:
Information provided by (Responsible Party):
Jill Stewart, PT, PhD, University of South Carolina

Brief Summary:
This study will examine the feasibility of providing task-oriented arm training in standing or during walking in individuals with movement deficits due to stroke. Participants will received 24 sessions of arm training in standing over an 8-week period that focus on arm and hand function.

Condition or disease Intervention/treatment Phase
Stroke Behavioral: Arm training in standing Not Applicable

Detailed Description:

Residual motor deficits are common after stroke and often have a negative impact on the performance of functional activities and overall quality of life. A frequently reported contribution to these functional limitations is an inability to incorporate the weaker arm and hand into daily activities. While rehabilitation interventions can improve arm functional capacity, these improvements often do not translate into increased real-world arm use which is often reduced after stroke.

The performance of skilled arm and hand movements in standing requires precise coordination between upper extremity movement and balance control. Many everyday functional tasks that require the arm are performed in standing (e.g. opening a door or meal preparation at the kitchen counter), however, training of arm function in rehabilitation is often done in sitting. An important rehabilitation approach may be to create a training environment that resembles the way the arm is used in everyday life (i.e. standing). This study will examine the feasibility of providing task-oriented, functional arm training in standing and during walking in individuals with motor deficits due to stroke.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Task-oriented Training of Arm Function in Standing After Stroke: a Pilot Study
Estimated Study Start Date : August 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
Experimental: Arm Training in Standing
Task-oriented, functional arm training completed in standing or during walking. All participants receive the same arm training intervention.
Behavioral: Arm training in standing
Arm training will be provided in one hour sessions, 3 time per week for 8 weeks. In each session, you will practice functional tasks with your weaker arm and hand in standing or during walking. Practice will be scaled to match your current level of function and progressed over time as able.




Primary Outcome Measures :
  1. Sessions Completed [ Time Frame: 8 weeks ]
    Total number of treatment sessions completed

  2. Fatigue [ Time Frame: 8 weeks ]
    Mean change in self-reported fatigue from the start to the end of each intervention session

  3. Treatment intensity [ Time Frame: 8 weeks ]
    Total number of arm repetitions per session and the percent of arm repetitions completed in standing or walking

  4. Action Research Arm Test [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of arm and hand function

  5. Arm Use Measured with Accelerometers [ Time Frame: Change from Baseline to 8 weeks ]
    Arm use measured during a typical day using accelerometers worn on the wrist


Secondary Outcome Measures :
  1. Upper Extremity Fugl-Meyer [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical Measure of arm and hand impairment

  2. Box & Blocks Test [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of hand function

  3. Nine-Hole Peg Test [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of hand dexterity

  4. Stroke Impact Scale Hand Domain Subscale [ Time Frame: Change from Baseline to 8 weeks ]
    Patient-reported measure of hand related quality-of-life. Score ranges from 0 to 100 with higher being better.

  5. Timed Up and Go [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of mobility and balance

  6. Activities Specific Balance Confidence Scale [ Time Frame: Change from Baseline to 8 weeks ]
    Patient-reported measure of balance confidence. Score ranges from 0 to 100 with higher being better


Other Outcome Measures:
  1. Berg Balance Scale [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of balance. 14-item performance measure with a maximum score of 56; higher score is better.

  2. Functional Gait Assessment [ Time Frame: Change from Baseline to 8 weeks ]
    Clinical measure of balance

  3. Stroke Impact Scale Mobility Subscale [ Time Frame: Change from Baseline to 8 weeks ]
    Patient-reported measure of mobility related quality-of-life. Score ranges from 0 to 100 with higher being better

  4. Action Research Arm Test [ Time Frame: Change from Baseline to 12 weeks ]
    Clinical measure of arm and hand function

  5. Arm Use Measured with Accelerometers [ Time Frame: Change from Baseline to 12 weeks ]
    Arm use measured during a typical day using accelerometers worn on the wrist



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • At least 18 years old
  • Had a stroke at least 6 months prior to enrollment
  • Show evidence of continued arm and hand weakness
  • Have some ability to move the arm and hand that is weaker from the stroke
  • Be able to stand with minimal assistance or less without support of the weaker arm for at least 2 minutes
  • Be able to follow two-step commands.

Exclusion Criteria:

  • Acute medical issues that would interfere with participation
  • Another neurologic diagnosis that may impact movement (e.g. Parkinson's Disease)
  • Severe apraxia or hemispatial neglect
  • Pain that interferes with arm movement or standing

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04050150


Contacts
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Contact: Jill Stewart, PT, PhD 803-777-6583 jcstewar@mailbox.sc.edu

Locations
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United States, South Carolina
University of South Carolina Recruiting
Columbia, South Carolina, United States, 29208
Sponsors and Collaborators
University of South Carolina
Investigators
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Principal Investigator: Jll Stewart, PT, PhD University of South Carolina

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Responsible Party: Jill Stewart, PT, PhD, Assistant Professor, University of South Carolina
ClinicalTrials.gov Identifier: NCT04050150     History of Changes
Other Study ID Numbers: Pro00080332
First Posted: August 8, 2019    Key Record Dates
Last Update Posted: August 8, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified data will be made available per reasonable request to the principal investigator 1 year after study completion.
Time Frame: 1 year after study completion

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jill Stewart, PT, PhD, University of South Carolina:
Rehabilitation
Upper Extremity
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases