Trial Outcomes & Findings for Neurophysiological and Kinematic Predictors of Response in Chronic Stroke (NCT NCT02658630)

Last Updated: 2021-03-02

Results Overview

The Stroke Impact Scale (SIS) is one of the primary outcome measures assessing change in hand 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 self-report structured interview consisting of eight domains designed to assess physical, mental and emotional changes following stroke that contribute to quality of life. It has been tested and found to be reliable, valid, and sensitive to change in the stroke population. It has four physical domain subscales that can be analyzed separately. The SIS hand subscale will be the focus for our outcome measure. Higher scores indicate greater function and life satisfaction. The minimum and maximum for the subscale is 0 and 100 respectively.

Recruitment status

COMPLETED

Study phase

Target enrollment

68 participants

Primary outcome timeframe

Baseline, after visit 36, and 12 week retention

Results posted on

2021-03-02

Participant Flow

There were 68 participants consented. Of these 46 were eligible and entered the intervention. Four did not complete due to transportation issues, scheduling conflicts or lack of communication.

Participant milestones

Participant milestones
Measure	Device: 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	46
Overall Study COMPLETED	42
Overall Study NOT COMPLETED	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Device: 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 Withdrawal by Subject	4

Baseline Characteristics

Neurophysiological and Kinematic Predictors of Response in Chronic Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Device: Robot + TTT Exercise n=42 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	27 Participants n=5 Participants
Age, Categorical >=65 years	15 Participants n=5 Participants
Age, Continuous	59.80952381 years STANDARD_DEVIATION 11.2818397 • n=5 Participants
Sex: Female, Male Female	15 Participants n=5 Participants
Sex: Female, Male Male	27 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 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	23 Participants n=5 Participants
Race (NIH/OMB) White	19 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
Region of Enrollment United States	42 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, after visit 36, and 12 week retention

Outcome measures

Outcome measures
Measure	Device: Robot + TTT Exercise n=42 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.
Stroke Impact Scale: Hand Baseline	20.4 score on a scale Standard Deviation 27.13
Stroke Impact Scale: Hand After visit 36	22.2 score on a scale Standard Deviation 24.26
Stroke Impact Scale: Hand 12-week retention visit	30.0 score on a scale Standard Deviation 30.57

PRIMARY outcome

Timeframe: Baseline, after visits 12, 24, and 36, and 12 week retention

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.

Outcome measures

Outcome measures
Measure	Device: Robot + TTT Exercise n=42 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.
Fugl-Meyer Upper Extremity Assessment Baseline	19.8 score on a scale Standard Deviation 9.62
Fugl-Meyer Upper Extremity Assessment After visit 12	22.2 score on a scale Standard Deviation 11.23
Fugl-Meyer Upper Extremity Assessment After visit 24	24.0 score on a scale Standard Deviation 13.08
Fugl-Meyer Upper Extremity Assessment After visit 36	24.4 score on a scale Standard Deviation 13.15
Fugl-Meyer Upper Extremity Assessment 12-week retention	25.2 score on a scale Standard Deviation 13.36

SECONDARY outcome

Timeframe: Baseline, after visits 12, 24, and 36, and 12 week retention

The ARAT will be used to assess change 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 arm motor function and 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. It includes 19 test activities and each test is given an ordinal score of 0, 1, 2, or 3, with higher values indicating better arm motor status. The total ARAT score is the sum of the 19 tests, and thus the maximum score is 57.

Outcome measures

Outcome measures
Measure	Device: Robot + TTT Exercise n=42 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.
Action Research Arm Test (ARAT) Baseline	14.4 score on a scale Standard Deviation 14.67
Action Research Arm Test (ARAT) After visit 12	14.9 score on a scale Standard Deviation 15.33
Action Research Arm Test (ARAT) After visit 24	16.2 score on a scale Standard Deviation 16.82
Action Research Arm Test (ARAT) After visit 36	16.4 score on a scale Standard Deviation 16.57
Action Research Arm Test (ARAT) 12-week retention	16.8 score on a scale Standard Deviation 17.73

SECONDARY outcome

Timeframe: Baseline, after visits 12, 24, and 36, and 12 week retention

The Streamlined 6-Item Wolf Motor Function Test (WMFT) will be used to assess change from baseline testing to mid-training after visits 12 and 24, and post-training after visit 36 and the 12 week retention period. It examines UE function based on task performance time, and quality of movement. Functional use and speed of movement are based on six timed activities. It has been examined in chronic stroke and has high inter-rater reliability, internal consistency, and test-retest reliability. Timed tasks that cannot be completed default to a time score of 120 seconds. Faster times or a lower score in seconds represent better function. The maximum score of 75 (minimum score 0) refers to perfect score on the full 15 item functional ability assessment (15 x 5.)

Outcome measures

Outcome measures
Measure	Device: Robot + TTT Exercise n=42 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.
6-Item Wolf Motor Function Test (WMFT) Baseline	1.7 units on a scale Standard Deviation 0.89
6-Item Wolf Motor Function Test (WMFT) After visit 12	1.8 units on a scale Standard Deviation 1.08
6-Item Wolf Motor Function Test (WMFT) After visit 24	1.9 units on a scale Standard Deviation 1.00
6-Item Wolf Motor Function Test (WMFT) After visit 36	2.0 units on a scale Standard Deviation 1.13
6-Item Wolf Motor Function Test (WMFT) 12-week retention	2.0 units on a scale Standard Deviation 1.20

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline, after visit 36, and 12 week retention

TMS stimulation of the motor cortex will be performed using MagStim 200 Magnetic Stimulators (MagStim Ltd., Wales, UK) at baseline and post training after visit 36 and the 12 week retention to assess change in the motor evoked potential (MEP) of the arm muscles. TMS testing is as follows: 1) Location of muscle hotspot (highest motor evoked potential), 2) Threshold (lowest stimulation strength that evokes an MEP at hotspot) 3) Ipsilateral silent period measured on both the affected and unaffected side. A score on the scale of 0-9, 9 indicating a greater nervous system response.

Outcome measures

Outcome measures
Measure	Device: Robot + TTT Exercise n=35 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.
TMS Score: Three Muscle Responses to Transcranial Magnetic Stimulation of the Motor Cortex Baseline	2.4 score on a scale Standard Deviation 2.80
TMS Score: Three Muscle Responses to Transcranial Magnetic Stimulation of the Motor Cortex After visit 36	2.6 score on a scale Standard Deviation 3.03
TMS Score: Three Muscle Responses to Transcranial Magnetic Stimulation of the Motor Cortex 12-week retention	2.5 score on a scale Standard Deviation 3.09

Adverse Events

Device: 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 F. Wittenberg

VA Pittsburgh Healthcare System

Phone: 412-648-4178

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place