Arm Training in Standing After Stroke

Sponsor
University of South Carolina (Other)
Overall Status
Completed
CT.gov ID
NCT04050150
Collaborator
(none)
12
1
1
29
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Study Details

Study Description

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
  • Behavioral: Arm training in standing
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
12 participants
Allocation:
N/A
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
Actual Study Start Date :
Jul 31, 2019
Actual Primary Completion Date :
Dec 31, 2021
Actual Study Completion Date :
Dec 31, 2021

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Sessions Completed [8 weeks]

    Total number of treatment sessions completed

  2. Fatigue [8 weeks]

    Mean change in self-reported fatigue from the start to the end of each intervention session

  3. Treatment intensity [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 [Change from Baseline to 8 weeks]

    Clinical measure of arm and hand function

  5. Arm Use Measured with Accelerometers [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 [Change from Baseline to 8 weeks]

    Clinical Measure of arm and hand impairment

  2. Box & Blocks Test [Change from Baseline to 8 weeks]

    Clinical measure of hand function

  3. Nine-Hole Peg Test [Change from Baseline to 8 weeks]

    Clinical measure of hand dexterity

  4. Stroke Impact Scale Hand Domain Subscale [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 [Change from Baseline to 8 weeks]

    Clinical measure of mobility and balance

  6. Activities Specific Balance Confidence Scale [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 [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 [Change from Baseline to 8 weeks]

    Clinical measure of balance

  3. Stroke Impact Scale Mobility Subscale [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 [Change from Baseline to 12 weeks]

    Clinical measure of arm and hand function

  5. Arm Use Measured with Accelerometers [Change from Baseline to 12 weeks]

    Arm use measured during a typical day using accelerometers worn on the wrist

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of South Carolina Columbia South Carolina United States 29208

Sponsors and Collaborators

  • University of South Carolina

Investigators

  • Principal Investigator: Jll Stewart, PT, PhD, University of South Carolina

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Jill Stewart, PT, PhD, Assistant Professor, University of South Carolina
ClinicalTrials.gov Identifier:
NCT04050150
Other Study ID Numbers:
  • Pro00080332
First Posted:
Aug 8, 2019
Last Update Posted:
Jan 12, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
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, Assistant Professor, University of South Carolina
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022