Arm Training in Standing After Stroke

Task-oriented Training of Arm Function in Standing After Stroke: a Pilot Study

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.

Study Overview

• Status: Completed
• Conditions: Stroke
• Intervention / Treatment: Behavioral: Arm training in standing

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Columbia, South Carolina, United States, 29208
      • University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sessions Completed	Total number of treatment sessions completed	8 weeks
Fatigue	Mean change in self-reported fatigue from the start to the end of each intervention session	8 weeks
Treatment intensity	Total number of arm repetitions per session and the percent of arm repetitions completed in standing or walking	8 weeks
Action Research Arm Test	Clinical measure of arm and hand function	Change from Baseline to 8 weeks
Arm Use Measured with Accelerometers	Arm use measured during a typical day using accelerometers worn on the wrist	Change from Baseline to 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Upper Extremity Fugl-Meyer	Clinical Measure of arm and hand impairment	Change from Baseline to 8 weeks
Box & Blocks Test	Clinical measure of hand function	Change from Baseline to 8 weeks
Nine-Hole Peg Test	Clinical measure of hand dexterity	Change from Baseline to 8 weeks
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.	Change from Baseline to 8 weeks
Timed Up and Go	Clinical measure of mobility and balance	Change from Baseline to 8 weeks
Activities Specific Balance Confidence Scale	Patient-reported measure of balance confidence. Score ranges from 0 to 100 with higher being better	Change from Baseline to 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale	Clinical measure of balance. 14-item performance measure with a maximum score of 56; higher score is better.	Change from Baseline to 8 weeks
Functional Gait Assessment	Clinical measure of balance	Change from Baseline to 8 weeks
Stroke Impact Scale Mobility Subscale	Patient-reported measure of mobility related quality-of-life. Score ranges from 0 to 100 with higher being better	Change from Baseline to 8 weeks
Action Research Arm Test	Clinical measure of arm and hand function	Change from Baseline to 12 weeks
Arm Use Measured with Accelerometers	Arm use measured during a typical day using accelerometers worn on the wrist	Change from Baseline to 12 weeks

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): July 31, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: August 6, 2019
• First Submitted That Met QC Criteria: August 7, 2019
• First Posted (Actual): August 8, 2019

Study Record Updates

• Last Update Posted (Actual): January 12, 2022
• Last Update Submitted That Met QC Criteria: January 10, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Rehabilitation; Upper Extremity
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Pro00080332

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD 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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No