Back to resultsEarly Independent Adaptive Arm and Hand Rehab
Primary Purpose
Post-stroke Hemiparesis
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Conventional Occupational Therapy (OT)
m2 BAT
Sponsored by
About this trial
This is an interventional treatment trial for Post-stroke Hemiparesis focused on measuring Motor control
Eligibility Criteria
Inclusion Criteria:
- Ability to follow study instructions
- Ability to likely complete all required visits
- Ability to comply with the therapy protocol as assessed by the investigator
- Must be English speaking
- Subjects must have had a unilateral stroke
Exclusion Criteria:
- Severe upper extremity spasticity suggested by an Ashworth score of ≥3 at any joint, or restriction of full passive range of motion.
- Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
- Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
- History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
- Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
- Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
- Patients who are cognitively impaired.
- Patients who lack capacity to consent.
Sites / Locations
- New York University Langone Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Conventional Occupational Therapy (OT)
OT + Device-assisted therapy
Arm Description
Standard of care occupational therapy for stroke recovery
Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy. The m2 BAT will enable repeated movement of the affected body part without the help of a therapist, providing the opportunity to maintain range-of motion in the affected limb to limit spasticity, contracture and the ensuing deformity, a major goal of rehabilitation therapy and produces movement in the affected limb from activating the patient's own brain, rather than from being acted on by an external powered source such as a robot.
Outcomes
Primary Outcome Measures
Performance tasks of the Fugl-Meyer Scale (FMS)
This measurement will be on a 3-point ordinal scale, ranging from 0-2 with a maximum score of 66.
Upper extremity functional ability measured with Modified Rankin Scale
Stroke-related quality of life measured with the Stroke Impact Scale
Spasticity measured using the Modified Ashworth Scale
Range of motion will be measured using video
Active/passive range of motion for shoulder flexion, extension, abduction, internal and external rotation, elbow flexion and extension, pronation and supination, wrist flexion and extension, radial and ulnar deviation will be measured for affected and unaffected arms.
Upper extremity functional ability measured using the Wolf Motor Function Test
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02749500
Brief Title
Early Independent Adaptive Arm and Hand Rehab
Official Title
Early Independent Adaptive Arm and Hand Rehabilitation Post Stroke
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
June 1, 2017 (Actual)
Primary Completion Date
January 19, 2018 (Actual)
Study Completion Date
January 19, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to test the hypothesis that early independent adaptive bimanual-to-unimanual training of arm and hand movements, assisted with specially designed mechanical devices: the mirrored motion bimanual arm trainer (m2 BAT), will improve motor control and function in patients with post-stroke hemiparesis.
Detailed Description
This study will randomly assign individuals admitted to the inpatient stroke rehabilitation unit to receive either conventional occupational therapy (OT) or conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post-stroke Hemiparesis
Keywords
Motor control
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional Occupational Therapy (OT)
Arm Type
Active Comparator
Arm Description
Standard of care occupational therapy for stroke recovery
Arm Title
OT + Device-assisted therapy
Arm Type
Experimental
Arm Description
Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy. The m2 BAT will enable repeated movement of the affected body part without the help of a therapist, providing the opportunity to maintain range-of motion in the affected limb to limit spasticity, contracture and the ensuing deformity, a major goal of rehabilitation therapy and produces movement in the affected limb from activating the patient's own brain, rather than from being acted on by an external powered source such as a robot.
Intervention Type
Other
Intervention Name(s)
Conventional Occupational Therapy (OT)
Intervention Description
Standard of care occupational therapy for stroke recovery
Intervention Type
Device
Intervention Name(s)
m2 BAT
Intervention Description
Conventional OT plus 1 hour additional bimanual-to-unimanual device-assisted therapy.
Primary Outcome Measure Information:
Title
Performance tasks of the Fugl-Meyer Scale (FMS)
Description
This measurement will be on a 3-point ordinal scale, ranging from 0-2 with a maximum score of 66.
Time Frame
12 Weeks
Title
Upper extremity functional ability measured with Modified Rankin Scale
Time Frame
12 Weeks
Title
Stroke-related quality of life measured with the Stroke Impact Scale
Time Frame
12 Weeks
Title
Spasticity measured using the Modified Ashworth Scale
Time Frame
12 Weeks
Title
Range of motion will be measured using video
Description
Active/passive range of motion for shoulder flexion, extension, abduction, internal and external rotation, elbow flexion and extension, pronation and supination, wrist flexion and extension, radial and ulnar deviation will be measured for affected and unaffected arms.
Time Frame
12 Weeks
Title
Upper extremity functional ability measured using the Wolf Motor Function Test
Time Frame
12 Weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Ability to follow study instructions
Ability to likely complete all required visits
Ability to comply with the therapy protocol as assessed by the investigator
Must be English speaking
Subjects must have had a unilateral stroke
Exclusion Criteria:
Severe upper extremity spasticity suggested by an Ashworth score of ≥3 at any joint, or restriction of full passive range of motion.
Evidence of alcohol, drug abuse or other relevant neuropsychiatric condition such as psychotic illness or severe depression.
Any condition or situation that, in the investigator's opinion, may put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
History of surgery or other significant injury to either upper extremity causing mechanical limitations that preclude task performance.
Previous neurological illness such as head trauma, prior stroke, epilepsy, or demyelinating disease.
Complicating medical problems such as uncontrolled hypertension, diabetes with signs of polyneuropathy, severe renal, cardiac or pulmonary disease, or evidence of other concurrent neurologic or orthopedic conditions precluding the subject from complying with the study protocol.
Patients who are cognitively impaired.
Patients who lack capacity to consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Tafurt, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Early Independent Adaptive Arm and Hand Rehab
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