Constraint-Induced Movement Therapy or CI Therapy is a form of treatment that systematically
      employs the application of selected behavioral techniques delivered in intensive treatment
      over consecutive day with the following strategies utilized: behavioral strategies are
      implemented to improve the use of the more- affected limb in life situation called a Transfer
      Package (TP), motor training using a technique called shaping to make progress in successive
      approximations, repetitive, task oriented training, and strategies to encourage or constrain
      participants to use the more-affected extremity including restraint of the less-affected arm
      in the upper extremity (UE) protocol. Numerous studies examining the application of CI
      therapy with UE rehabilitation after stroke have demonstrated strong evidence for improving
      the amount of use and the quality of the more-affected UE functional use in the participant's
      daily life situation.

      CI Therapy studies with adults, to date, have explored intensive treatment for participants
      with a range from mild-to-severe motor impairment following stroke with noted motor deficits
      and limited use of the more-affected arm and hand in everyday activities. Each CI Therapy
      protocol was designed for the level of impairment demonstrated by participants recruited for
      the study. However, often following stroke, patients not only have motor deficits but
      somatosensory impairments as well. The somatosensory issues have not, as yet, been
      systematically measured and trained in CI Therapy protocols with adults and represent an
      understudied area of stroke recovery. We hypothesize that participants with mild-to-severe
      motor impairment and UE functional use deficits can benefit from CI therapy protocols that
      include somatosensory measurement and training components substituted for portions of motor
      training without loss in outcome measure gains. Further, we hypothesize that adults can
      improve somatosensory outcomes as a result of a combined CI therapy plus somatosensory
      component protocol.

Constraint-Induced Movement Therapy Plus Sensory Components After Stroke

CVA (Cerebrovascular Accident)

Stroke

Upper Extremity Paresis

The purpose of this study is to systematically examine the feasibility of adding
      somatosensory components to CI Therapy protocols for patients having mild-to-severe
      impairment to improve more-affected UE use, motor ability, and sensory perception in the
      chronic phase of stroke recovery. Treatment will follow previous timeframes of CI Therapy
      protocols of 2 weeks of intervention for mild-to-moderate UE impairment and 3 weeks for
      severe UE impairment. The Motor Activity Log (MAL) and Grade 4/5 Motor Activity Log (G4/5
      MAL) are used to measure use of the more affected UE by participants with mild-to-moderate
      impairment and severe impairment, respectively. Motor capacity is measured by the Wolf Motor
      Function Test (WMFT) for those with mild-to-moderate impairment and the Grade 5 - Graded Wolf
      Motor Function Test (G5-GWMFT) for those with severe UE impairment. Participants: 12
      post-stroke participants in the chronic phase of recovery (at least 6 months post-stroke)
      will be enrolled. Participants in this study must at least meet the minimal motor criteria
      for severely impaired participants. Thus, prior to treatment, participants must be able to
      demonstrate movement more-affected UE including the ability to move the shoulder ≥ 30 toward
      flexion or abduction, initiate movement at the elbow for flexion and extension, and initiate
      movement at the wrist, fingers, or thumb. Outcome Measures: Aim 1 will be assessed using the
      MAL (Arm use) for mild-to-moderately impaired participants or the G4/5 MAL (Arm use) for
      severely impaired participants, WMFT (UE motor capacity) for mild-to-moderately impaired and
      G5-GWMFT (UE motor capacity) for severely impaired participants, SIS (Stroke Impact Scale -
      Quality of Life), Zung Depression Scale (ZDS-Mood), and Canadian Occupational Performance
      Measure (COPM - Functional activity preference, ability and satisfaction). All measures will
      be administered immediately pre-treatment and at post-treatment. The MAL or G4/5 MAL, SIS,
      COPM, and ZDS will also be administered at 3 months post-intervention by telephone. Aim 2
      will be assessed by Revised Nottingham Sensory Assessment (rNSA-Sensation) and Semmes &
      Weinstein Monofilament Test (SWMT- Sensation). These measures will be performed immediately
      pre-treatment and at post-treatment. Intervention: Participants will receive CI therapy plus
      somatosensory training components for the more-affected upper extremity for 2-3 weeks
      (depending on the level of UE impairment severity) for 3.5 hours per weekday. Specific CI
      therapy strategies will be delivered as is described with the addition of somatosensory
      components for the more-affected arm and hand. CI therapy strategies include: 1.) supervised
      movement training for 3.5 hours 5 weekdays x 2-3 weeks; 2.) participants will wear a
      restraint mitt on the less-affected hand for the majority of their waking hours for the 2-3
      weeks; 3.) a transfer package will be used to help the participant transfer their gains from
      the laboratory to the life situation. Sensory components may be used to increase sensory
      input to the brain and increase the attention of each participant to the more-affected UE.
      The sensory components may include 1.) sensory stimulation to the more-affected UE (e.g.;
      brushing the UE with soft bristle brush, vibration to the finger tips, massage to the UE,
      etc); 2.) sensory training tasks that require each participant to respond to what is felt
      through the UE (e.g.; object identification, temperature discrimination, material
      identification, etc.)

Grade 2-5 CI Therapy + Sensory Components

Constraint-Induced Movement Therapy Plus Sensory Components for Adults With Mild-to-Severe Arm and Hand Impairment After Stroke

The Motor Activity Log is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 30 activities of daily living. This test is used to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting and in the life situation. It is administered before and after treatment. The score is derived from two scales that are each 0-5 and reported as a mean for the Amount of Use (AOU) and mean for the Quality of Use (QOM).

The G4/5 Motor Activity Log is a semi-structured interview that assesses the amount of use and the quality of use of the more-affected UE in 30 activities of daily living. This test is used to determine the change how much and how well the participant uses the more-affected arm and hand outside of the laboratory setting and in the life situation. It is administered before and after treatment. The score is derived from two scales that are each 0-5 and reported as a mean for the Amount of Use (AOU) and mean for the Quality of Use (QOM).

The WMFT is a standardized performance capacity test that measures the motor ability of the upper extremities of a participant. The performance time is measured using a stopwatch and a functional ability (quality) score is provided for each item tested. This test 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 time represents a better performance.

The G5 Graded WMFT is a standardized motor performance test that measures the motor ability of the upper extremities of a participant. The performance time is measured using a stopwatch and the 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 0-7 with 0 representing the participant's inability to perform the task, and 7 representing normal movement or as good as before the stroke, such that a higher functional ability score is better. A lower performance time represents a better performance.

The COPM is a semi-structured interview in which the participant is asked to rate their desired occupational performance areas in activities of daily living and instrumental activities of daily living. The COPM is used to show changes in the 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.

Assistant Professor

The ZDS is a 20-item self-report questionnaire that measures symptoms of depression. A total score is calculated by summing the individual items. The range of the scores is 20-80. Higher scores indicate more symptoms with a score of 70 or higher as severe depression. Administered before treatment, after treatment, and in followup at 3 months out from the treatment to detect changes in mood.

The ZDS is a 20-item self-report questionnaire that measures symptoms of depression. A total score is calculated by summing the individual items. The range of the scores is 20-80. Higher scores indicate more symptoms with a score of 70 or higher as severe. on. A total score is calculated by summing the individual items. The range of the scores is 20-80. Higher scores indicate more symptoms with a score of 70 or higher as severe depression. Administered before treatment, after treatment, and in follow-up at 3 months out from the treatment to detect changes in mood.

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.

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.

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

The PO Survey is a self-report measure that measures the participant's perspective and feelings about treatment components and use of the more-affected arm and hand. It is administered before treatment, half way through treatment, and at the end of treatment.

All participants will receive CI Therapy + Sensory Components administered over the specific time frame of 2-3 weeks.

Constraint-Induced Movement Therapy Plus Sensory Components After Stroke

About this trial

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Placebo

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