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Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment

Primary Purpose

CVA (Cerebrovascular Accident), Stroke, Upper Extremity Paresis

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Grade 1 CI Therapy +Sensory Components
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for CVA (Cerebrovascular Accident)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 6 months post stroke
  • The ability to demonstrate the minimum UE active movement criteria of 20 degrees of wrist extension from a fully flexed position, 10 degrees of thumb extension or abduction, and 10 degrees of extension of all finger joints.
  • Mean score of >2.5 on the Motor Activity Log indicating the participant's use of the more-affected UE.

Exclusion Criteria:

  • Score< 24 on the Mini Mental State Exam
  • Inability to answer the MAL questions and/or provide informed consent
  • The inability to come in to the laboratory setting for treatment.

Sites / Locations

  • University of Alabama at BirminghamRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Grade 1 CI Therapy + Sensory Components

Arm Description

All participants will receive the Grade 1 CI Therapy + Sensory Components administered over a two-week period of time.

Outcomes

Primary Outcome Measures

45-Item Motor Activity Log (MAL)
The 45-Item MAL is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 45 activities of daily living. The use of this test is to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting. It is administered before and after treatment. The score is derived from a 0-5 scale and reported as a mean for the Amount of Use (AOU) and the Quality of Use (QOM).
45-Item Motor Activity Log (MAL)
The 45-Item MAL is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 45 activities of daily living. The use of this test is to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting. It is administered before and after treatment. The score is derived from a 0-5 scale and reported as a mean for the Amount of Use (AOU) and the Quality of Use (QOM).
Wolf Motor Function Test (WMFT)
The WMFT is a standardized test that measures the motor ability of the upper extremities of a participant. The performance time by stopwatch is recorded and functional ability (quality) score is provided for each item tested. It is administered before treatment and after treatment. The quality of movement is rated by the therapist on a scale from 0-5 with 0 representing the participant's inability to perform the task, and 5 representing normal movement or as good as before the stroke, such that a higher functional ability score is better. A lower performance represents a better performance.
Canadian Occupational Performance Measure (COPM)
The COPM is a semi structured interview in which the participant is asked to rate desired occupational performance areas for activities of daily living and instrumental activities of daily living. The COPM is used to show changes in performance and satisfaction in desired areas of occupational performance. There are three scales used in the COPM administration one for importance, performance, and satisfaction. The scales range from 1-10 with the higher score indicating an improvement in the score.
Canadian Occupational Performance Measure (COPM)
The COPM is a semi structured interview in which the participant is asked to rate desired occupational performance areas for activities of daily living and instrumental activities of daily living. The COPM is used to show changes in performance and satisfaction in desired areas of occupational performance. There are three scales used in the COPM administration one for importance, performance, and satisfaction. The scales range from 1-10 with the higher score indicating an improvement in the score.

Secondary Outcome Measures

Beck Depression Inventory (BDI)
The BDI is a self-reported test with 21 items that measures the symptoms of depression. Scores range from 1-40+ with 11-16 as mild mood disturbance, 17-20 borderline clinical depression, 21-30 moderate depression, 31-40 severe depression and over 40 extreme depression. The BDI administered before treatment, after treatment, and in follow up at 3 months out from treatment to detect changes in mood.
Beck Depression Inventory (BDI)
The BDI is a self-reported test with 21 items that measures the symptoms of depression. Scores range from 1-40+ with 11-16 as mild mood disturbance, 17-20 borderline clinical depression, 21-30 moderate depression, 31-40 severe depression and over 40 extreme depression. The BDI administered before treatment, after treatment, and in follow up at 3 months out from treatment to detect changes in mood.
Stroke Impact Scale (SIS)
The SIS is a self-report measure of 8 domains of quality of life and disability following stroke. The scoring can range from 1-100 with a higher score indicating a better quality of life and less disability. The SIS is administered in this study at pre-treatment, post-treatment and 3 month follow-up to detect changes in quality of life as a result of the treatment.
Stroke Impact Scale (SIS)
The SIS is a self-report measure of 8 domains of quality of life and disability following stroke. The scoring can range from 1-100 with a higher score indicating a better quality of life and less disability. The SIS is administered in this study at pre-treatment, post-treatment and 3 month follow-up to detect changes in quality of life as a result of the treatment.
9 Hole Peg Test (9HPT)
The 9HPT measures finger dexterity. The performance time of placing all pegs and removing them again is recorded. The mean time of two trials is determined and the better the performance.
Revised Nottingham Sensory Assessment (rNSA)
The rNSA measures somatosensory impairments following stroke. The scores range from 0-2 with 0 representing absent sensation and 2 representing normal sensation while proprioception is scored as 0-3 with 0 representing absent and 3 representing joint position sense < 10 degrees. Only the upper extremity portion will be tested and his test will be used to detect changes in sensation in the upper extremity as a result of treatment.
Semmes-Weinstein Monofilament Test (SWMT)
The SWMT measures touch pressure with monofilaments of different diameters. The smaller the diameter of the monofilament, the more difficult to detect.

Full Information

First Posted
August 4, 2022
Last Updated
December 9, 2022
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT05492513
Brief Title
Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment
Official Title
Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment and Deficits in Desired Occupational Performance: A Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
December 8, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
March 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

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
Constraint-Induced Therapy (CI Therapy) is a behavioral approach to neurorehabilitation and consists of multi-components that have been applied in a systematic method to improve the use of the limb or function addressed in the intensive treatment. CI Therapy for the more-affected upper extremity (UE) post-stroke is administered in daily treatment sessions over consecutive weekdays. Sessions include motor training with repeated, timed trials using a technique called shaping, a set of behavioral strategies known as the Transfer Package (TP) to improve the use of the more-affected hand in the life situation, and strategies to remind participants to use the more-affected UE including restraint. Robust improvements in the amount and qualify of use have been realized with stroke participants from mild-to-severe UE impairment.
Detailed Description
Previous CI therapy studies have explored treatment for participants with varied levels of motor impairment from mild-to-severe that have limited use of the more-affected arm and hand in everyday activities as measured by the Motor Activity Log (MAL). The Motor Activity Log (MAL) is a standardized test used in CI therapy studies to measure the Amount of Use and the Quality of Use of the more-affected UE in the life situation. Individuals that exceed maximal criteria with a mean MAL score higher than 2.5 are typically excluded from CI therapy studies since they potentially would hit a ceiling effect on the MAL and would not be able to show a meaningful treatment change. Similarly, in a clinical setting, these individuals are often discharged from outpatient therapy as having reached the maximum benefit of traditional therapy since each can typically perform basic skills with the more-affected UE despite the disparity of continued difficulty with performing high-level motor tasks and persistent sensory deficits. However, these patients often voice strong motivation to gain more recovery and return to performing activities of daily living (ADL) and instrumental activities of daily living (IADL)that require complex motor skills (i.e.; keyboarding, texting, utensil or tool use, musical instrument use, etc). We hypothesize that participants with mild UE movement deficits will benefit from CI therapy with focused intervention to address skills and performance of high-level tasks and outcome measures that are selected for this level of patient. We further question if adding sensory components to the CI therapy strategies will improve the participant's sensation for the more-affected UE and aid in the more-affected UE use in everyday tasks but particularly in challenging motor tasks.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
CVA (Cerebrovascular Accident), Stroke, Upper Extremity Paresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Grade 1 CI Therapy + Sensory Components
Arm Type
Experimental
Arm Description
All participants will receive the Grade 1 CI Therapy + Sensory Components administered over a two-week period of time.
Intervention Type
Behavioral
Intervention Name(s)
Grade 1 CI Therapy +Sensory Components
Intervention Description
All participants will receive Grade 1 CI Therapy + Sensory Components over a two-week period of time. The treatment intervention will include all CI Therapy treatment strategies including: 1) supervised motor training in the form of shaping with repeated trials and task practice for 3.5 hours per day for 5 weekdays for 2 weeks 2) a behavioral Transfer Package (TP) will be employed to aid carry-over of skills gained by the participant in the laboratory to the life situation 3) each participant will wear a mitt on the less-affected hand for most of their waking hours to encourage use of the more-affected hand 4) participants will be given home assignments to be carried out for at least 30 minutes each day. Sensory component strategies will be added to stimulate sensory input through the more-affected arm and hand as well as to train sensory discrimination skills.
Primary Outcome Measure Information:
Title
45-Item Motor Activity Log (MAL)
Description
The 45-Item MAL is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 45 activities of daily living. The use of this test is to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting. It is administered before and after treatment. The score is derived from a 0-5 scale and reported as a mean for the Amount of Use (AOU) and the Quality of Use (QOM).
Time Frame
At post treatment after 2 weeks of intervention
Title
45-Item Motor Activity Log (MAL)
Description
The 45-Item MAL is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 45 activities of daily living. The use of this test is to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting. It is administered before and after treatment. The score is derived from a 0-5 scale and reported as a mean for the Amount of Use (AOU) and the Quality of Use (QOM).
Time Frame
At 3 months after the end of the treatment
Title
Wolf Motor Function Test (WMFT)
Description
The WMFT is a standardized test that measures the motor ability of the upper extremities of a participant. The performance time by stopwatch is recorded and functional ability (quality) score is provided for each item tested. It is administered before treatment and after treatment. The quality of movement is rated by the therapist on a scale from 0-5 with 0 representing the participant's inability to perform the task, and 5 representing normal movement or as good as before the stroke, such that a higher functional ability score is better. A lower performance represents a better performance.
Time Frame
At post treatment after the 2 weeks of intervention
Title
Canadian Occupational Performance Measure (COPM)
Description
The COPM is a semi structured interview in which the participant is asked to rate desired occupational performance areas for activities of daily living and instrumental activities of daily living. The COPM is used to show changes in performance and satisfaction in desired areas of occupational performance. There are three scales used in the COPM administration one for importance, performance, and satisfaction. The scales range from 1-10 with the higher score indicating an improvement in the score.
Time Frame
At post-treatment after the 2 weeks of intervention
Title
Canadian Occupational Performance Measure (COPM)
Description
The COPM is a semi structured interview in which the participant is asked to rate desired occupational performance areas for activities of daily living and instrumental activities of daily living. The COPM is used to show changes in performance and satisfaction in desired areas of occupational performance. There are three scales used in the COPM administration one for importance, performance, and satisfaction. The scales range from 1-10 with the higher score indicating an improvement in the score.
Time Frame
At follow-up at 3 months following the end of treatment.
Secondary Outcome Measure Information:
Title
Beck Depression Inventory (BDI)
Description
The BDI is a self-reported test with 21 items that measures the symptoms of depression. Scores range from 1-40+ with 11-16 as mild mood disturbance, 17-20 borderline clinical depression, 21-30 moderate depression, 31-40 severe depression and over 40 extreme depression. The BDI administered before treatment, after treatment, and in follow up at 3 months out from treatment to detect changes in mood.
Time Frame
At post- treatment following the 2 weeks of treatment
Title
Beck Depression Inventory (BDI)
Description
The BDI is a self-reported test with 21 items that measures the symptoms of depression. Scores range from 1-40+ with 11-16 as mild mood disturbance, 17-20 borderline clinical depression, 21-30 moderate depression, 31-40 severe depression and over 40 extreme depression. The BDI administered before treatment, after treatment, and in follow up at 3 months out from treatment to detect changes in mood.
Time Frame
At 3 month follow up from the end of the 2 weeks of treatment.
Title
Stroke Impact Scale (SIS)
Description
The SIS is a self-report measure of 8 domains of quality of life and disability following stroke. The scoring can range from 1-100 with a higher score indicating a better quality of life and less disability. The SIS is administered in this study at pre-treatment, post-treatment and 3 month follow-up to detect changes in quality of life as a result of the treatment.
Time Frame
At post-treatment following the 2 weeks of treatment
Title
Stroke Impact Scale (SIS)
Description
The SIS is a self-report measure of 8 domains of quality of life and disability following stroke. The scoring can range from 1-100 with a higher score indicating a better quality of life and less disability. The SIS is administered in this study at pre-treatment, post-treatment and 3 month follow-up to detect changes in quality of life as a result of the treatment.
Time Frame
At 3 months following the end of the 2 weeks of treatment.
Title
9 Hole Peg Test (9HPT)
Description
The 9HPT measures finger dexterity. The performance time of placing all pegs and removing them again is recorded. The mean time of two trials is determined and the better the performance.
Time Frame
At post-treatment after the 2 weeks of intervention
Title
Revised Nottingham Sensory Assessment (rNSA)
Description
The rNSA measures somatosensory impairments following stroke. The scores range from 0-2 with 0 representing absent sensation and 2 representing normal sensation while proprioception is scored as 0-3 with 0 representing absent and 3 representing joint position sense < 10 degrees. Only the upper extremity portion will be tested and his test will be used to detect changes in sensation in the upper extremity as a result of treatment.
Time Frame
At post-treatment after the 2 weeks of intervention
Title
Semmes-Weinstein Monofilament Test (SWMT)
Description
The SWMT measures touch pressure with monofilaments of different diameters. The smaller the diameter of the monofilament, the more difficult to detect.
Time Frame
At post-treatment after the 2 weeks of intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 6 months post stroke The ability to demonstrate the minimum UE active movement criteria of 20 degrees of wrist extension from a fully flexed position, 10 degrees of thumb extension or abduction, and 10 degrees of extension of all finger joints. Mean score of >2.5 on the Motor Activity Log indicating the participant's use of the more-affected UE. Exclusion Criteria: Score< 24 on the Mini Mental State Exam Inability to answer the MAL questions and/or provide informed consent The inability to come in to the laboratory setting for treatment.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mary H Bowman, BS OT
Phone
2059340069
Email
mbowman@uab.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Morris, PhD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Study Chair
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary H Bowman, BS OT
Phone
205-934-0069
Email
mbowman@uab.edu

12. IPD Sharing Statement

Plan to Share IPD
No
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Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment

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