search
Back to results

Arm Training in Standing After Stroke

Primary Purpose

Stroke

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Arm training in standing
Sponsored by
University of South Carolina
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stroke focused on measuring Rehabilitation, Upper Extremity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South Carolina

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Arm Training in Standing

Arm Description

Task-oriented, functional arm training completed in standing or during walking. All participants receive the same arm training intervention.

Outcomes

Primary Outcome Measures

Sessions Completed
Total number of treatment sessions completed
Fatigue
Mean change in self-reported fatigue from the start to the end of each intervention session
Treatment intensity
Total number of arm repetitions per session and the percent of arm repetitions completed in standing or walking
Action Research Arm Test
Clinical measure of arm and hand function
Arm Use Measured with Accelerometers
Arm use measured during a typical day using accelerometers worn on the wrist

Secondary Outcome Measures

Upper Extremity Fugl-Meyer
Clinical Measure of arm and hand impairment
Box & Blocks Test
Clinical measure of hand function
Nine-Hole Peg Test
Clinical measure of hand dexterity
Stroke Impact Scale Hand Domain Subscale
Patient-reported measure of hand related quality-of-life. Score ranges from 0 to 100 with higher being better.
Timed Up and Go
Clinical measure of mobility and balance
Activities Specific Balance Confidence Scale
Patient-reported measure of balance confidence. Score ranges from 0 to 100 with higher being better

Full Information

First Posted
August 6, 2019
Last Updated
January 10, 2022
Sponsor
University of South Carolina
search

1. Study Identification

Unique Protocol Identification Number
NCT04050150
Brief Title
Arm Training in Standing After Stroke
Official Title
Task-oriented Training of Arm Function in Standing After Stroke: a Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
July 31, 2019 (Actual)
Primary Completion Date
December 31, 2021 (Actual)
Study Completion Date
December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Carolina

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stroke
Keywords
Rehabilitation, Upper Extremity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm Training in Standing
Arm Type
Experimental
Arm Description
Task-oriented, functional arm training completed in standing or during walking. All participants receive the same arm training intervention.
Intervention Type
Behavioral
Intervention Name(s)
Arm training in standing
Intervention Description
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 Measure Information:
Title
Sessions Completed
Description
Total number of treatment sessions completed
Time Frame
8 weeks
Title
Fatigue
Description
Mean change in self-reported fatigue from the start to the end of each intervention session
Time Frame
8 weeks
Title
Treatment intensity
Description
Total number of arm repetitions per session and the percent of arm repetitions completed in standing or walking
Time Frame
8 weeks
Title
Action Research Arm Test
Description
Clinical measure of arm and hand function
Time Frame
Change from Baseline to 8 weeks
Title
Arm Use Measured with Accelerometers
Description
Arm use measured during a typical day using accelerometers worn on the wrist
Time Frame
Change from Baseline to 8 weeks
Secondary Outcome Measure Information:
Title
Upper Extremity Fugl-Meyer
Description
Clinical Measure of arm and hand impairment
Time Frame
Change from Baseline to 8 weeks
Title
Box & Blocks Test
Description
Clinical measure of hand function
Time Frame
Change from Baseline to 8 weeks
Title
Nine-Hole Peg Test
Description
Clinical measure of hand dexterity
Time Frame
Change from Baseline to 8 weeks
Title
Stroke Impact Scale Hand Domain Subscale
Description
Patient-reported measure of hand related quality-of-life. Score ranges from 0 to 100 with higher being better.
Time Frame
Change from Baseline to 8 weeks
Title
Timed Up and Go
Description
Clinical measure of mobility and balance
Time Frame
Change from Baseline to 8 weeks
Title
Activities Specific Balance Confidence Scale
Description
Patient-reported measure of balance confidence. Score ranges from 0 to 100 with higher being better
Time Frame
Change from Baseline to 8 weeks
Other Pre-specified Outcome Measures:
Title
Berg Balance Scale
Description
Clinical measure of balance. 14-item performance measure with a maximum score of 56; higher score is better.
Time Frame
Change from Baseline to 8 weeks
Title
Functional Gait Assessment
Description
Clinical measure of balance
Time Frame
Change from Baseline to 8 weeks
Title
Stroke Impact Scale Mobility Subscale
Description
Patient-reported measure of mobility related quality-of-life. Score ranges from 0 to 100 with higher being better
Time Frame
Change from Baseline to 8 weeks
Title
Action Research Arm Test
Description
Clinical measure of arm and hand function
Time Frame
Change from Baseline to 12 weeks
Title
Arm Use Measured with Accelerometers
Description
Arm use measured during a typical day using accelerometers worn on the wrist
Time Frame
Change from Baseline to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jll Stewart, PT, PhD
Organizational Affiliation
University of South Carolina
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Carolina
City
Columbia
State/Province
South Carolina
ZIP/Postal Code
29208
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
De-identified data will be made available per reasonable request to the principal investigator 1 year after study completion.
IPD Sharing Time Frame
1 year after study completion

Learn more about this trial

Arm Training in Standing After Stroke

We'll reach out to this number within 24 hrs