Arm Training in Standing After Stroke

NCT04050150 | Completed

• 1 other identifier: Pro00080332
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Stroke

Keywords

Rehabilitation; Upper Extremity

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (6)

• Upper Extremity Fugl-Meyer

  Change from Baseline to 8 weeks

• Box & Blocks Test

  Change from Baseline to 8 weeks

• Nine-Hole Peg Test

  Change from Baseline to 8 weeks

• Stroke Impact Scale Hand Domain Subscale

  Change from Baseline to 8 weeks

• Timed Up and Go

  Change from Baseline to 8 weeks

Other Outcomes (5)

• Berg Balance Scale

  Change from Baseline to 8 weeks

• Functional Gait Assessment

  Change from Baseline to 8 weeks

• Stroke Impact Scale Mobility Subscale

  Change from Baseline to 8 weeks

Study Arms (1)

Arm Training in Standing

EXPERIMENTAL

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

Behavioral: Arm training in standing

Interventions

Arm training in standing BEHAVIORAL

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.

Arm Training in Standing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Carolina: lead

Study Sites (1)

University of South Carolina

Columbia, South Carolina, 29208, United States

Location

MeSH Terms

Conditions

Stroke

Interventions

Standing Position

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Posture; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jll Stewart, PT, PhD

  University of South Carolina

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 6, 2019
• First Posted: August 8, 2019
• Study Start: July 31, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: January 12, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Time Frame: 1 year after study completion

Locations

US (1)