Trial Outcomes & Findings for Predictors of Response in Chronic Stroke (NCT NCT04283253)

Last Updated: 2022-03-03

Results Overview

The Fugl-Meyer is one of the primary outcome measures assessing change in arm use from baseline testing to mid-training after visits 12 and 24, and post-training after visit 36 and the 12 week retention period. It is a stroke-specific measure of impairment of the upper extremity that has been shown to be valid and reliable with high inter-rater and test-retest reliability. It provides a direct-observational assessment of volitional movement and motor impairment related to reflexes, sensation, and abnormal synergies. Each item on the FM is rated on a three-point ordinal scale (0 = cannot perform, 1 = performs partially, 2 = performs fully). The scale ranges from 0-66 with higher scores representing less motor impairment.

Recruitment status

COMPLETED

Study phase

Target enrollment

1 participants

Primary outcome timeframe

Immediately following the 12-week intervention

Results posted on

2022-03-03

Participant Flow

Participant milestones

Participant milestones
Measure	Robot + TTT Exercise All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises. Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.
Overall Study STARTED	1
Overall Study COMPLETED	1
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Predictors of Response in Chronic Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Robot + TTT Exercise n=1 Participants All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises. Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Immediately following the 12-week intervention

Population: Only one subject was enrolled and data collection was incomplete due to the Covid-19 pandemic. The evaluations following the 12-week intervention were not performed.

Outcome measures

Outcome measures
Measure	Robot + TTT Exercise n=1 Participants All participants will be enrolled in this group to receive the same 60 minute study intervention consisting of wrist and shoulder-elbow robot training and TTT arm exercises. Robot + TTT exercise: The intervention will be completed 36 visits approximately 3x/week for 12-18 weeks. The training progression will be sequential with 12 visits completed on the wrist robot, followed by 12 visits on the shoulder-elbow robot and completing with 12 visits alternating sessions on the wrist and shoulder-elbow robot. Participants will perform robot training for 45 minutes with each robot followed by 15 minutes of TTT practice to complete their 60 minute intervention session.
A Change in the Fugl-Meyer Upper Extremity Assessment Score Baseline One	11 units on a scale
A Change in the Fugl-Meyer Upper Extremity Assessment Score After Visit 24	14 units on a scale
A Change in the Fugl-Meyer Upper Extremity Assessment Score Baseline Two	12 units on a scale
A Change in the Fugl-Meyer Upper Extremity Assessment Score After Visit 12	13 units on a scale

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately following the 12-week intervention

Population: Only one subject was enrolled and data collection was incomplete due to the Covid-19 pandemic. The evaluations (including TMS) following the 12-week intervention were not performed.

TMS stimulation of the motor cortex will be performed using MagStim 200 Magnetic Stimulators (MagStim Ltd., Wales, UK) to assess change in the motor evoked potential (MEP) of the arm muscles.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Immediately following the 12-week intervention

Population: MRI was not collected as the one enrolled subject did not pass the MRI safety screening.

A detailed analysis of the MRI data will examine individual interregional connections to determine whether any of them are more sensitive to the intervention than others.

Outcome measures

Outcome data not reported

Adverse Events

Robot + TTT Exercise

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

George Wittenberg

UNIVERSITY OF PITTSBURGH

Phone: 4126484178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place