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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 : December 11, 2020
Sponsor:
Information provided by (Responsible Party):
Kessler Foundation

Tracking Information
First Submitted Date  ICMJE January 10, 2019
First Posted Date  ICMJE January 25, 2019
Last Update Posted Date December 11, 2020
Actual Study Start Date  ICMJE June 28, 2017
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • 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
  • 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.
  • 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.
  • 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
  • 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
  • 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
  • Change in brain structural connectivity (DTI) [ Time Frame: Pretest (before training), Posttest (immediately after end of training) ]
    cerebrospinal tract connectivity
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 24, 2019)
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical and Mental Practice for Bimanual Coordination Rehabilitation
Official Title  ICMJE Combining Physical and Mental Practice for the Rehabilitation of Upper Extremity Movement Impairments Secondary to Traumatic Brain Injury
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.
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE
  • Traumatic Brain Injury
  • Weakness, Muscle
  • Coordination Impairment
Intervention  ICMJE
  • 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
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Hand coordination and mental practice
  • 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.
    Intervention: Behavioral: Hand coordination and action observation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 24, 2019)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2021
Estimated Primary Completion Date May 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Michael Glassen 973-324-3525 mglassen@kesslerfoundation.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03817086
Other Study ID Numbers  ICMJE R970-17
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Kessler Foundation
Study Sponsor  ICMJE Kessler Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Soha Saleh, PhD Kessler Foundation
PRS Account Kessler Foundation
Verification Date December 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP