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Physical and Mental Practice for Bimanual Coordination Rehabilitation

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ClinicalTrials.gov Identifier: NCT03817086
Recruitment Status : Recruiting
First Posted : January 25, 2019
Last Update Posted : January 25, 2019
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation

Brief Summary:
Traumatic Brain Injury (TBI)patients often suffer from loss of muscle strength in the hand and foot, decrease in coordination and high muscle tone (spasticity). In this study, investigators seek to compare how two different training programs can improve the coordination and symptoms of fatigue in individuals with movement deficits secondary to TBI. Using brain imaging, the study will also investigate changes in brain structure and activity associated with hand movement.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Weakness, Muscle Coordination Impairment Behavioral: Hand coordination and mental practice Behavioral: Hand coordination and action observation Not Applicable

Detailed Description:

Moderate and severe Traumatic Brain Injury (TBI) commonly causes upper extremity physical impairments that persist even after years of injury; these deficits are attributed to damage in brain structure and changes in structural and functional connectivity. Bimanual coordination deficits and muscle weakness have a significant impact on TBI survivors' well-being, and conventional therapy did not provide high success in treating these two issues. The investigators relate this lag in efficiency to two main reasons: 1) absence of outcome measures to quantify these deficits in a clinical setting, and 2) mental and cognitive fatigue and short attention span in TBI survivors, which limits the feasibility to enroll TBI survivors in intensive training protocols.

The investigators long-term goal is to provide effective rehabilitation training to help TBI survivors in regaining proper bimanual coordination of hand movement and higher hand muscles' strength. Mental practice includes motor imagery and action observation, and neural imaging studies have shown that both motor imagery and action observation share similar neural mechanism as movement execution. In addition, interventional studies have shown success in combining physical and mental practice to improve motor function of stroke survivors, and it does not induce muscle fatigue.

Hence, the first aim of this pilot study is to compare the therapeutic efficacy of combining physical practice with mental practice (motor imagery and action observation) (MP) versus physical practice only with action observation (PP) alone to improve hand bimanual coordination and muscle strength of TBI survivors. Twenty subjects will be randomly and equally assigned to either of two training groups. Maximum Voluntary Contraction (MVC), Reaction Time (RT), and Percent of Error in Matching (PEM) a Target will be used as primary outcome measures in addition to functional-based measures (Wolf Motor Function Test WMFT). In addition, activation maps (functional MRI data) will be established for the brain neural networks before and after training. The investigator's second aim is to study if either or both interventions (MP and PP) induce reorganization in brain activity and in functional (at rest) and effective (during a task) connectivity.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Combining Physical and Mental Practice for the Rehabilitation of Upper Extremity Movement Impairments Secondary to Traumatic Brain Injury
Actual Study Start Date : June 28, 2017
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Hand coordination and mental practice
In a total of 12 training sessions (days), 3 sessions per week over 4 weeks, participants practice physical in-phase and out-of-phase movement of both limbs for 40 minutes. Every 10 minutes, participants get a 2 minutes break during which the participants are asked to mentally imagine doing the task with an action observation of perfect performance.
Behavioral: Hand coordination and mental practice

20 chronic (>1year) moderate to severe TBI patients, with upper extremity movement deficits, will be randomly and equally assigned to two groups.

In the experimental group, participants undergo 5 weeks (3 hrs/week) of physical practice training combined with mental practice (MP group).

Other Name: experimental group

Active Comparator: Hand coordination and action observation
In a total of 12 training sessions (days), 3 sessions per week over 4 weeks, participants practice physical in-phase and out-of-phase movement of both limbs for 40 minutes. Every 10 minutes, participants get a 2 minutes break during which the participants are asked to observe a visual feedback of performance.
Behavioral: Hand coordination and action observation
In the control group 2, participants undergo 5 weeks (3 hrs/week) of physical training (PP group).
Other Name: control group




Primary Outcome Measures :
  1. Change in Maximum voluntary contraction [ Time Frame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training) ]
    maximum force exerted by each hand during squeezing a handgrip force sensor

  2. Change in Reaction Time [ Time Frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12 ]
    Reaction time is the time between real movement, and the time participant was instructed to move. This reaction time will be recorded for every training trial. The average of reaction time in each training day (total 12) will be used to examine the change in performance (slope) across the 12 training days, from day 1 until day 12 of the intervention.

  3. Change in Percent of Error in force matching [ Time Frame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12 ]
    Percent of error is the mismatch between the force exerted by the participant and the required force as per the instructions in each training trial. This Percent of Error will be recorded for every training trial. The average of errors in each training day (total 12) will be used to examine the change (slope) in performance across the 12 sessions (days) of the intervention.

  4. Change in wolf motor function test [ Time Frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training) ]
    assessment of upper extremity function

  5. Change in within-brain effective connectivity [ Time Frame: Pretest (before training), Posttest (immediately after end of training) ]
    connectivity between sensorimotor and attention network during inphase and out-phase hand coordination task

  6. Change in resting state function connectivity [ Time Frame: Pretest (before training), Posttest (immediately after end of training) ]
    connectivity between sensorimotor and attention network at rest

  7. Change in brain structural connectivity (DTI) [ Time Frame: Pretest (before training), Posttest (immediately after end of training) ]
    cerebrospinal tract connectivity


Secondary Outcome Measures :
  1. stroop effect test [ Time Frame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training) ]
    neuropsychology assessments of reaction time

  2. trail making test [ Time Frame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training) ]
    neuropsychology assessments of task switching and visual attention



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • between the ages of 20 to 60 years old.
  • have been diagnosed with a moderate to severe Traumatic Brain Injury.
  • must have had the injury more than 12 months ago.
  • have problems controlling my arm movements.
  • right handed.
  • speak and understand English.
  • willing and able to travel to Kessler Foundation in West Orange, NJ for the 3 testing sessions and the 12 sessions of intervention.
  • must have stable health with no expected medication changes for the next 4 months.
  • able to understand instructions that are part of the testing and intervention.

Exclusion Criteria:

  • have had a penetrating Traumatic Brain Injury.
  • have severe spasticity (stiffness and tightness in my muscles) as determined by study staff.
  • have had other brain injuries or illnesses in addition to the Traumatic Brain Injury (for example, epilepsy, MS).
  • use illegal substances at this time, like drugs
  • have had a brain injury that was non-traumatic such as a stroke or brain tumor.
  • am enrolled in another research study that is likely to affect my participation in this research study.
  • have a history of psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817086


Contacts
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Contact: Michael Glassen 973-324-3525 mglassen@kesslerfoundation.org

Locations
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United States, New Jersey
Kessler Foundation Recruiting
West Orange, New Jersey, United States, 07052
Contact: Matthew Weiner    973-324-3515    mweiner@kesslerfoundation.org   
Principal Investigator: Soha Saleh, PhD         
Sponsors and Collaborators
Kessler Foundation
Investigators
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Principal Investigator: Soha Saleh, PhD Kessler Foundation

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Responsible Party: Kessler Foundation
ClinicalTrials.gov Identifier: NCT03817086     History of Changes
Other Study ID Numbers: R970-17
First Posted: January 25, 2019    Key Record Dates
Last Update Posted: January 25, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Brain Diseases
Muscle Weakness
Ataxia
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Muscular Diseases
Musculoskeletal Diseases
Neuromuscular Manifestations
Neurologic Manifestations
Pathologic Processes
Signs and Symptoms
Dyskinesias