Trial Outcomes & Findings for Robotic Training for Stroke Neurorehabilitation (NCT NCT02639390)
NCT ID: NCT02639390
Last Updated: 2021-01-13
Results Overview
The Fugl-Meyer Test of Motor Function will be used to assess motor impairments at the shoulder, elbow, wrist and fingers. The Fugl-Meyer test scores reflexes and the ability to perform several movements and tasks on a 3-point scale. The Fugl-Meyer was designed for the recovery patterns observed after stroke and is very responsive to change in severe and moderately impaired subjects.
TERMINATED
PHASE2
5 participants
Change from baseline to 8 weeks
2021-01-13
Participant Flow
Participant milestones
| Measure |
Robotic
The experimental group will receive 1-hour robotic training sessions, 3 times per week for a total of 12 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive the same dosage and schedule (1-hour sessions, 3 times/week, 12 total sessions) of conventional one-on-one therapy from an occupational therapist.
Robotic Therapy: Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects.
Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement.
|
Conventional
Subjects will receive 24 hours of one-on-one treatment from an occupational therapist. The treatment schedule will parallel that given to the experimental group (1-hour sessions, 3 times/week).
Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement.
|
|---|---|---|
|
Overall Study
STARTED
|
0
|
5
|
|
Overall Study
COMPLETED
|
0
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
Reasons for withdrawal
| Measure |
Robotic
The experimental group will receive 1-hour robotic training sessions, 3 times per week for a total of 12 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive the same dosage and schedule (1-hour sessions, 3 times/week, 12 total sessions) of conventional one-on-one therapy from an occupational therapist.
Robotic Therapy: Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects.
Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement.
|
Conventional
Subjects will receive 24 hours of one-on-one treatment from an occupational therapist. The treatment schedule will parallel that given to the experimental group (1-hour sessions, 3 times/week).
Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement.
|
|---|---|---|
|
Overall Study
Subject unable to comply with treatment schedule.
|
0
|
2
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Robotic
The experimental group will receive 1-hour robotic training sessions, 3 times per week for a total of 12 sessions supervised by a research assistant. Immediately following this robot training, these subjects will receive the same dosage and schedule (1-hour sessions, 3 times/week, 12 total sessions) of conventional one-on-one therapy from an occupational therapist.
Robotic Therapy: Subjects will be placed in the robot and practice common upper extremity tasks involving grasping, manipulating and moving objects.
Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement.
|
Conventional
n=5 Participants
Subjects will receive 24 hours of one-on-one treatment from an occupational therapist. The treatment schedule will parallel that given to the experimental group (1-hour sessions, 3 times/week).
Conventional Therapy: An occupational therapist will provide one-on-one individualized programs focused on arm function. Treatment will focus on practice of specific tasks, such as reach, grasp, transport and release of various objects between different targets. Progression is done by varying the shape, size and weight of objects, altering the end range of the target or increasing the speed of movement.
|
Total
n=5 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
—
|
2 Participants
n=5 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
—
|
3 Participants
n=5 Participants
|
3 Participants
n=5 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
—
|
5 participants
n=5 Participants
|
5 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: No data available for analysis.
The Fugl-Meyer Test of Motor Function will be used to assess motor impairments at the shoulder, elbow, wrist and fingers. The Fugl-Meyer test scores reflexes and the ability to perform several movements and tasks on a 3-point scale. The Fugl-Meyer was designed for the recovery patterns observed after stroke and is very responsive to change in severe and moderately impaired subjects.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: No data available for analysis.
The Action Research Arm Test (ARAT) is an impairment level measurement tool that assesses the functional limitations of the upper extremities. It is one of the most frequently used primary endpoints in upper extremity (UE) training trials in stroke. The assessment incorporates 19 items that are divided into four subscales: Grasp, Grip, Pinch, and Gross movement. Item scores are summed to form a subtest score, and then a full-scale score.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Change from baseline to 8 weeksPopulation: No data available for analysis.
The Motor Activity Log (MAL) will be used to assess use of the limb at home. It is a structured interview during which respondents are asked to rate how they use their more-impaired arm for 28 activities of daily living (ADL) in the home over a specified period. Activities include brushing teeth, buttoning a shirt or blouse, and eating with a fork or spoon.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Change from baseline to 8 monthsPopulation: No data available for analysis.
The Fugl-Meyer Test of Motor Function will be used to assess motor impairments at the shoulder, elbow, wrist and fingers. The Fugl-Meyer test scores reflexes and the ability to perform several movements and tasks on a 3-point scale. The Fugl-Meyer was designed for the recovery patterns observed after stroke and is very responsive to change in severe and moderately impaired subjects.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Change from baseline to 8 monthsPopulation: No data available for analysis.
The Action Research Arm Test (ARAT) is an impairment level measurement tool that assesses the functional limitations of the upper extremities. It is one of the most frequently used primary endpoints in upper extremity (UE) training trials in stroke. The assessment incorporates 19 items that are divided into four subscales: Grasp, Grip, Pinch, and Gross movement. Item scores are summed to form a subtest score, and then a full-scale score.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Change from baseline to 8 monthsPopulation: No data available for analysis.
The Motor Activity Log (MAL) will be used to assess use of the limb at home. It is a structured interview during which respondents are asked to rate how they use their more-impaired arm for 28 activities of daily living (ADL) in the home over a specified period. Activities include brushing teeth, buttoning a shirt or blouse, and eating with a fork or spoon.
Outcome measures
Outcome data not reported
Adverse Events
Robotic
Conventional
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