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Physical and Mental Practice for Bimanual Coordination Rehabilitation

Primary Purpose

Traumatic Brain Injury, Weakness, Muscle, Coordination Impairment

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hand coordination and mental practice
Hand coordination and action observation
Sponsored by
Kessler Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Traumatic Brain Injury

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Kessler Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Hand coordination and mental practice

Hand coordination and action observation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Maximum voluntary contraction
maximum force exerted by each hand during squeezing a handgrip force sensor
Change in Reaction Time
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
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
assessment of upper extremity function
Change in within-brain effective connectivity
connectivity between sensorimotor and attention network during inphase and out-phase hand coordination task
Change in resting state function connectivity
connectivity between sensorimotor and attention network at rest
Change in brain structural connectivity (DTI)
cerebrospinal tract connectivity

Secondary Outcome Measures

stroop effect test
neuropsychology assessments of reaction time
trail making test
neuropsychology assessments of task switching and visual attention

Full Information

First Posted
January 10, 2019
Last Updated
October 12, 2022
Sponsor
Kessler Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03817086
Brief Title
Physical and Mental Practice for Bimanual Coordination Rehabilitation
Official Title
Combining Physical and Mental Practice for the Rehabilitation of Upper Extremity Movement Impairments Secondary to Traumatic Brain Injury
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 28, 2017 (Actual)
Primary Completion Date
May 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Kessler Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Weakness, Muscle, Coordination Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hand coordination and mental practice
Arm Type
Experimental
Arm Description
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.
Arm Title
Hand coordination and action observation
Arm Type
Active Comparator
Arm Description
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 Type
Behavioral
Intervention Name(s)
Hand coordination and mental practice
Other Intervention Name(s)
experimental group
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Hand coordination and action observation
Other Intervention Name(s)
control group
Intervention Description
In the control group 2, participants undergo 5 weeks (3 hrs/week) of physical training (PP group).
Primary Outcome Measure Information:
Title
Change in Maximum voluntary contraction
Description
maximum force exerted by each hand during squeezing a handgrip force sensor
Time Frame
Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
Title
Change in Reaction Time
Description
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.
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
Title
Change in Percent of Error in force matching
Description
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.
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
Title
Change in wolf motor function test
Description
assessment of upper extremity function
Time Frame
Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Title
Change in within-brain effective connectivity
Description
connectivity between sensorimotor and attention network during inphase and out-phase hand coordination task
Time Frame
Pretest (before training), Posttest (immediately after end of training)
Title
Change in resting state function connectivity
Description
connectivity between sensorimotor and attention network at rest
Time Frame
Pretest (before training), Posttest (immediately after end of training)
Title
Change in brain structural connectivity (DTI)
Description
cerebrospinal tract connectivity
Time Frame
Pretest (before training), Posttest (immediately after end of training)
Secondary Outcome Measure Information:
Title
stroop effect test
Description
neuropsychology assessments of reaction time
Time Frame
Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
Title
trail making test
Description
neuropsychology assessments of task switching and visual attention
Time Frame
Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soha Saleh, PhD
Organizational Affiliation
Kessler Foundation
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kessler Foundation
City
West Orange
State/Province
New Jersey
ZIP/Postal Code
07052
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Physical and Mental Practice for Bimanual Coordination Rehabilitation

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