NCT05251077

Harmony Scapulohumeral Rhythm (SHR) Reliability and Efficacy Study

Safety, Reliability, and Efficacy of the Harmony SHR Upper Extremity Robotic Rehabilitation System in the Inpatient Rehabilitation Setting for Patients With Acute Stroke

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Shirley Ryan AbilityLab · Academic / Other
• Sex: All
• Age: 21 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the safety, reliability, and efficacy of the use of the Harmony Scapulohumeral Rhythm (SHR) upper extremity robotic rehabilitation system for persons with impaired functional use of one or both upper extremities due to stroke.

Detailed description

Once recruited, subjects will be randomly assigned to traditional or intervention groups. Subjects in the traditional therapy group will receive up to 24 sessions of traditional occupational therapy intervention focusing on upper limb task training. Subjects in the intervention group will receive up to 24 sessions of functional task training using the Harmony SHR device. These sessions will be conducted by a trained researcher or licensed occupational therapist. Outcome measures will be assessed prior to the first intervention session and following the last intervention session, prior to discharge from inpatient rehabilitation.

Conditions

• Stroke, Acute

Interventions

Type	Name	Description
DEVICE	Harmony SHR	Functional task training with use of Harmony SHR device
OTHER	Traditional Occupational Therapy	Functional task training of affected limb

Timeline

• Start date: 2022-01-01
• Primary completion: 2023-05-30
• Completion: 2023-05-30
• First posted: 2022-02-22
• Last updated: 2026-02-24
• Results posted: 2026-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study