Physical and Mental Practice for Bimanual Coordination Rehabilitation

Traumatic Brain Injury Clinical Trial

Official title:

Combining Physical and Mental Practice for the Rehabilitation of Upper Extremity Movement Impairments Secondary to Traumatic Brain Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03817086
• Other study ID #: R970-17
• Status: Completed
• Phase: N/A
• Start date: June 28, 2017
• Est. completion date: June 30, 2021

Study information

• Verified date: October 2022
• Source: Kessler Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: June 30, 2021
• Est. primary completion date: May 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 60 Years

Eligibility

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).

Related Conditions & MeSH terms

• Ataxia
• Brain Injuries
• Brain Injuries, Traumatic
• Coordination Impairment
• Muscle Weakness
• Traumatic Brain Injury
• Weakness, Muscle

Intervention

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).
• Hand coordination and action observation
In the control group 2, participants undergo 5 weeks (3 hrs/week) of physical training (PP group).

Locations

Country	Name	City	State
United States	Kessler Foundation	West Orange	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Kessler Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Maximum voluntary contraction	maximum force exerted by each hand during squeezing a handgrip force sensor	Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
Primary	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.	day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12
Primary	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.	day 1, day 2, day 3, day 4, day 5, day 6, day 7, day 8, day 9, day 10, day 11, day 12
Primary	Change in wolf motor function test	assessment of upper extremity function	Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
Primary	Change in within-brain effective connectivity	connectivity between sensorimotor and attention network during inphase and out-phase hand coordination task	Pretest (before training), Posttest (immediately after end of training)
Primary	Change in resting state function connectivity	connectivity between sensorimotor and attention network at rest	Pretest (before training), Posttest (immediately after end of training)
Primary	Change in brain structural connectivity (DTI)	cerebrospinal tract connectivity	Pretest (before training), Posttest (immediately after end of training)
Secondary	stroop effect test	neuropsychology assessments of reaction time	Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
Secondary	trail making test	neuropsychology assessments of task switching and visual attention	Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)