Clinical trial NCT03817086: 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
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Weakness, Muscle
Coordination Impairment
Lead sponsor: Kessler Foundation
Sponsor class: OTHER
First posted: 2019-01-25
Enrollment: 19
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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).

Primary outcomes:
measure: Change in Maximum voluntary contraction
timeFrame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
measure: Change in Reaction Time
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12
measure: Change in Percent of Error in force matching
timeFrame: day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12
measure: Change in wolf motor function test
timeFrame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
measure: Change in within-brain effective connectivity
timeFrame: Pretest (before training), Posttest (immediately after end of training)
measure: Change in resting state function connectivity
timeFrame: Pretest (before training), Posttest (immediately after end of training)
measure: Change in brain structural connectivity (DTI)
timeFrame: Pretest (before training), Posttest (immediately after end of training)
Secondary outcomes:
measure: stroop effect test
timeFrame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
measure: trail making test
timeFrame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
Other outcomes:
Locations:
city: West Orange
country: United States
facility: Kessler Foundation
state: New Jersey
Study officials:
affiliation: Kessler Foundation
name: Soha Saleh, PhD
role: PRINCIPAL_INVESTIGATOR
References: