Effects of Post-Stroke Upper Extremity Assistance

NCT ID: NCT05036642

Last Updated: 2023-10-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-07-26
• Study Completion Date: 2022-09-07

Brief Summary

The purpose of this study is to quantify the improvement of post- stroke individuals' ability to move their arms during and after robot assisted therapy.

While researchers know that robot assisted therapies improve motor performance over the course of weeks, they do not know how motor performance is affected over the course of minutes or hours. A better understanding of how robot assisted therapies affect motor performance on short time scales may help us to prescribe more effective therapy doses to maximize motor recovery after neurological injury.

The study will allow us to obtain a detailed understanding of the performance of the device as described above.

Conditions

Arm Weakness as a Consequence of Stroke

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Stroke Survivors

Stroke survivors with upper extremity motor impairments

Group Type: EXPERIMENTAL

Compliant Passive Arm Support

Intervention Type: DEVICE

The device is a mechanical device that consists of two linkages, elastic bands, a commercial posture brace, and a hook-and-loop fastener. The design of the device, with several compliant elements, ensures that one device fits many without joint alignment concerns. No motors or other actuators add energy into the system, meaning that it is stable.

Interventions

Compliant Passive Arm Support

The device is a mechanical device that consists of two linkages, elastic bands, a commercial posture brace, and a hook-and-loop fastener. The design of the device, with several compliant elements, ensures that one device fits many without joint alignment concerns. No motors or other actuators add energy into the system, meaning that it is stable.

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• greater than 6 months post-stroke
• passive abduction to 90 degrees at shoulder
• reduced active (retro)flexion/extension at shoulder when abducted at 90 degrees
• reduced active flexion/extension at elbow

Exclusion Criteria

• unable to give informed consent
• unable to comprehend and follow instructions
• have a condition (other than stroke) affecting sensorimotor function
• show evidence of unilateral spatial neglect
• unable to sit in a chair without armrests for 2 hours

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Allison Okamura

Professor of Mechanical Engineering

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Allison Okamura

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University CHARM Lab

Stanford, California, United States

Countries

United States

References

Sukal TM, Ellis MD, Dewald JP. Shoulder abduction-induced reductions in reaching work area following hemiparetic stroke: neuroscientific implications. Exp Brain Res. 2007 Nov;183(2):215-23. doi: 10.1007/s00221-007-1029-6. Epub 2007 Jul 20.

Reference Type: BACKGROUND

PMID: 17634933 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

SNI-BI1-02

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

IRB-61540

Identifier Type: -

Identifier Source: org_study_id