Trial Outcomes & Findings for Harmony Scapulohumeral Rhythm (SHR) Reliability and Efficacy Study (NCT NCT05251077)
NCT ID: NCT05251077
Last Updated: 2026-02-24
Results Overview
The Upper Extremity Fugl-Meyer Assessment (UE FMA) is a 33 item stroke-specific, performance-based impairment index designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. For the purposes of this study, only the upper extremity motor functioning domain will be assessed. This domain is comprised of assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. Scoring is based on direct observation of performance and items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0 = cannot perform, 1 = performs partially, and 2 = performs fully. Total score range is from 0 to 66, with a higher total score indicates less impairment of the UE being tested.
COMPLETED
NA
21 participants
Prior to intervention start, day 1, and prior to discharge from inpatient rehabilitation (on average day 21) and the change in score will be recorded.
2026-02-24
Participant Flow
Participant milestones
| Measure |
Optimization Group
Up to 10 participants will be enrolled to identify optimal device application in the acute stroke population. These participants will not be randomized into the intervention group or control group. They will receive the same treatment as the intervention group. The purpose of this group is to 1) train study staff prior to randomization and 2) ensure that the inclusion/exclusion criteria is adequate.
Harmony SHR: Functional task training with use of Harmony SHR device
|
Active Control
Participants in this group will receive traditional occupational therapy up to 24 sessions, 60 minutes in length, during the participant's inpatient rehabilitation stay.
Traditional Occupational Therapy: Functional task training of affected limb
|
Intervention
Participants in this group will receive functional task training with use of the Harmony SHR device up to 24 sessions, 60 minutes in length, during the participant's inpatient rehabilitation stay.
Harmony SHR: Functional task training with use of Harmony SHR device
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
10
|
10
|
|
Overall Study
COMPLETED
|
1
|
10
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Harmony Scapulohumeral Rhythm (SHR) Reliability and Efficacy Study
Baseline characteristics by cohort
| Measure |
Intervention
n=10 Participants
Participants in this group will receive functional task training with use of the Harmony SHR device up to 24 sessions, 60 minutes in length, during the participant's inpatient rehabilitation stay.
Harmony SHR: Functional task training with use of Harmony SHR device
|
Total
n=21 Participants
Total of all reporting groups
|
Optimization Group
n=1 Participants
Up to 10 participants will be enrolled to identify optimal device application in the acute stroke population. These participants will not be randomized into the intervention group or control group. They will receive the same treatment as the intervention group. The purpose of this group is to 1) train study staff prior to randomization and 2) ensure that the inclusion/exclusion criteria is adequate.
Harmony SHR: Functional task training with use of Harmony SHR device
|
Active Control
n=10 Participants
Participants in this group will receive traditional occupational therapy up to 24 sessions, 60 minutes in length, during the participant's inpatient rehabilitation stay.
Traditional Occupational Therapy: Functional task training of affected limb
|
|---|---|---|---|---|
|
Age, Customized
|
62 years
n=1 Participants
|
61.9 years
n=484 Participants
|
44 years
n=58 Participants
|
61.8 years
|
|
Sex: Female, Male
Female
|
3 Participants
n=1 Participants
|
6 Participants
n=484 Participants
|
1 Participants
n=58 Participants
|
2 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=1 Participants
|
15 Participants
n=484 Participants
|
0 Participants
n=58 Participants
|
8 Participants
|
|
Race/Ethnicity, Customized
Black/African American
|
5 Participants
n=1 Participants
|
12 Participants
n=484 Participants
|
1 Participants
n=58 Participants
|
6 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=1 Participants
|
8 Participants
n=484 Participants
|
0 Participants
n=58 Participants
|
4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=1 Participants
|
1 Participants
n=484 Participants
|
0 Participants
n=58 Participants
|
0 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - Hispanic
|
1 Participants
n=1 Participants
|
1 Participants
n=484 Participants
|
0 Participants
n=58 Participants
|
0 Participants
|
|
Race/Ethnicity, Customized
Ethnicity - non-Hispanic
|
9 Participants
n=1 Participants
|
19 Participants
n=484 Participants
|
0 Participants
n=58 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Prior to intervention start, day 1, and prior to discharge from inpatient rehabilitation (on average day 21) and the change in score will be recorded.The Upper Extremity Fugl-Meyer Assessment (UE FMA) is a 33 item stroke-specific, performance-based impairment index designed to assess motor functioning, balance, sensation, and joint functioning in patients with post-stroke hemiplegia. For the purposes of this study, only the upper extremity motor functioning domain will be assessed. This domain is comprised of assessing movement, coordination, and reflex action of the shoulder, elbow, forearm, wrist, and hand. Scoring is based on direct observation of performance and items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0 = cannot perform, 1 = performs partially, and 2 = performs fully. Total score range is from 0 to 66, with a higher total score indicates less impairment of the UE being tested.
Outcome measures
| Measure |
Optimization Group
n=1 Participants
Up to 10 participants will be enrolled to identify optimal device application in the acute stroke population. These participants will not be randomized into the intervention group or control group. They will receive the same treatment as the intervention group. The purpose of this group is to 1) train study staff prior to randomization and 2) ensure that the inclusion/exclusion criteria is adequate.
Harmony SHR: Functional task training with use of Harmony SHR device
|
Active Control
n=10 Participants
Participants in this group will receive traditional occupational therapy up to 24 sessions, 60 minutes in length, during the participant's inpatient rehabilitation stay.
Traditional Occupational Therapy: Functional task training of affected limb
|
Intervention
n=10 Participants
Participants in this group will receive functional task training with use of the Harmony SHR device up to 24 sessions, 60 minutes in length, during the participant's inpatient rehabilitation stay.
Harmony SHR: Functional task training with use of Harmony SHR device
|
|---|---|---|---|
|
Upper Extremity Fugl-Meyer Assessment (UE FMA)
|
6 score on scale
Interval 6.0 to 6.0
|
9.5 score on scale
Interval 1.0 to 33.0
|
8.2 score on scale
Interval 1.0 to 18.0
|
SECONDARY outcome
Timeframe: Prior to intervention start, day 1, and prior to discharge from inpatient rehabilitation (on average day 21) and the change in score will be recordedThe Action Research Arm Test (ARAT) is a 19 item observational measure used to assess upper extremity performance (coordination, dexterity, and functioning) in stroke recovery, brain injury, and multiple sclerosis. Items comprising the ARAT are categorized into 4 subscales (grasp, grip, pinch, gross motor) and arranged in order of decreasing difficulty, with the most difficult task examined first, followed by the least difficult task. Task performance is rated on a 4-point scale, ranging from 0 (no movement) to 3 (movement performed normally). Score ranges from 0-57. Higher total score indicates more function of the UE being tested.
Outcome measures
| Measure |
Optimization Group
n=1 Participants
Up to 10 participants will be enrolled to identify optimal device application in the acute stroke population. These participants will not be randomized into the intervention group or control group. They will receive the same treatment as the intervention group. The purpose of this group is to 1) train study staff prior to randomization and 2) ensure that the inclusion/exclusion criteria is adequate.
Harmony SHR: Functional task training with use of Harmony SHR device
|
Active Control
n=10 Participants
Participants in this group will receive traditional occupational therapy up to 24 sessions, 60 minutes in length, during the participant's inpatient rehabilitation stay.
Traditional Occupational Therapy: Functional task training of affected limb
|
Intervention
n=10 Participants
Participants in this group will receive functional task training with use of the Harmony SHR device up to 24 sessions, 60 minutes in length, during the participant's inpatient rehabilitation stay.
Harmony SHR: Functional task training with use of Harmony SHR device
|
|---|---|---|---|
|
Action Research Arm Test (ARAT)
|
5 score on scale
Interval 5.0 to 5.0
|
7.5 score on scale
Interval -1.0 to 17.0
|
6.9 score on scale
Interval -3.0 to 19.0
|
Adverse Events
Optimization Group
Active Control
Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place