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NCT Number: NCT05492513

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

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.

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Key information

Conditions

CVA (Cerebrovascular Accident) Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Neurologic Manifestations Paresis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stroke Upper Extremity Paresis Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location status: Recruiting

Location contact

Mary H Bowman, BS OT

CONTACT

[email protected]

2059340069

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Grade 1 CI Therapy +Sensory Components

Behavioral

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 1.5 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 outcomes

  1. 45-Item Motor Activity Log (MAL)

    Time frame: At post treatment after 2 weeks of intervention

    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).

  2. 45-Item Motor Activity Log (MAL)

    Time frame: At 3 months after the end of the treatment

    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).

  3. Wolf Motor Function Test (WMFT)

    Time frame: At post treatment after the 2 weeks of intervention

    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.

  4. Canadian Occupational Performance Measure (COPM)

    Time frame: At post-treatment after the 2 weeks of intervention

    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.

  5. Canadian Occupational Performance Measure (COPM)

    Time frame: At follow-up at 3 months following the end of treatment.

    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 outcomes

  1. Beck Depression Inventory (BDI)

    Time frame: At post- treatment following the 2 weeks of treatment

    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.

  2. Beck Depression Inventory (BDI)

    Time frame: At 3 month follow up from the end of the 2 weeks of treatment.

    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.

  3. Stroke Impact Scale (SIS)

    Time frame: At post-treatment following the 2 weeks of treatment

    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.

  4. Stroke Impact Scale (SIS)

    Time frame: At 3 months following the end of the 2 weeks of treatment.

    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.

  5. 9 Hole Peg Test (9HPT)

    Time frame: At post-treatment after the 2 weeks of intervention

    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.

  6. Revised Nottingham Sensory Assessment (rNSA)

    Time frame: At post-treatment after the 2 weeks of intervention

    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.

  7. Semmes-Weinstein Monofilament Test (SWMT)

    Time frame: At post-treatment after the 2 weeks of intervention

    The SWMT measures touch pressure with monofilaments of different diameters. The smaller the diameter of the monofilament, the more difficult to detect.

Study contacts

Contact information is provided by the study sponsor or research team.

Mary H Bowman, BS OT

CONTACT

[email protected]

2059340069

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Registry information

Official study title

Constraint-Induced Movement Therapy for Adults Post-Stroke With Mild Upper Extremity Impairment and Deficits in Desired Occupational Performance: A Pilot Study

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Aug 8, 2022
Registry last updated
Feb 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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