Trial Outcomes & Findings for Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke (NCT NCT01244243)

Results Overview

The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

41 participants

Primary outcome timeframe

change from baseline to 1 month post-end treatment, Intention To Treat

Results posted on

2016-08-18

Participant Flow

Participant milestones

Participant milestones
Measure	Active Therapy All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
Overall Study STARTED	41
Overall Study COMPLETED	41
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Robot-Assisted Hand Motor Therapy for Subjects With Hemiparetic Stroke

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Therapy n=41 Participants All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment. Hand \& Wrist Assisting Robotic Device: Treatment occurs in 2 hour sessions, 4 times a week over 3 weeks.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	30 Participants n=93 Participants
Age, Categorical >=65 years	11 Participants n=93 Participants
Age, Continuous	59 years STANDARD_DEVIATION 14 • n=93 Participants
Sex: Female, Male Female	11 Participants n=93 Participants
Sex: Female, Male Male	30 Participants n=93 Participants
Region of Enrollment United States	41 participants n=93 Participants

PRIMARY outcome

Timeframe: change from baseline to 1 month post-end treatment, Intention To Treat

The Action Research Arm Test is a 19 item measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale ranging from: 3: Performs test normally 2: Completes test, but takes abnormally long or has great difficulty 1: Performs test partially 0: Can perform no part of test. The test is used to determine upper limb function, 0-57 points with higher is better, 57 is the highest score indicating normal arm movement.

Outcome measures

Outcome measures
Measure	Active Therapy n=41 Participants All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
Action Research Arm Test	4.1 units on a scale Interval 2.3 to 5.9

PRIMARY outcome

Timeframe: change from baseline to 1 month post-end treatment, Intention To Treat

The Arm Motor Fugl-Meyer test is an assessment of Sensorimotor Recovery After Stroke. It is a 33 item measure with 3 subgroups which are Proximal, Wrist/Hand, and Coordination/Speed. The scaling for each item works on a scale of 0-2 with 0 being not able to be done, 1 being partially done, and 2 being done normally. The scoring goes from 0-66, higher is better, 66 is considered a normal score with no noticable complications in movement.

Outcome measures

Outcome measures
Measure	Active Therapy n=41 Participants All subjects receive the same active robotic therapy, there is no placebo arm, as a key goal of this study is to define predictors of response to active treatment.
Arm Motor Fugl-Meyer Test	3.7 units on a scale Interval 2.7 to 4.8

Adverse Events

Active Therapy

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

Steve Cramer

University of California, Irvine

Phone: 7144566876

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place