Physical and Mental Practice for Bimanual Coordination Rehabilitation

NCT03817086 | Completed DMC

• 1 other identifier: R970-17
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Weakness, Muscle; Coordination Impairment

Outcome Measures

Primary Outcomes (7)

• 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)

• 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

• 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

• 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)

• 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)

• Change in resting state function connectivity

  connectivity between sensorimotor and attention network at rest

  Pretest (before training), Posttest (immediately after end of training)

• Change in brain structural connectivity (DTI)

  cerebrospinal tract connectivity

  Pretest (before training), Posttest (immediately after end of training)

Secondary Outcomes (2)

• stroop effect test

  Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)

• trail making test

  Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)

Study Arms (2)

Hand coordination and mental practice

EXPERIMENTAL

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

Hand coordination and action observation

ACTIVE COMPARATOR

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

Interventions

Hand coordination and mental practice BEHAVIORAL

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).

Also known as: experimental group

Hand coordination and mental practice

Hand coordination and action observation BEHAVIORAL

In the control group 2, participants undergo 5 weeks (3 hrs/week) of physical training (PP group).

Also known as: control group

Hand coordination and action observation

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Kessler Foundation: lead

Study Sites (1)

Kessler Foundation

West Orange, New Jersey, 07052, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Muscle Weakness; Ataxia

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; 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; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Dyskinesias

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Soha Saleh, PhD

  Kessler Foundation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2019
• First Posted: January 25, 2019
• Study Start: June 28, 2017
• Primary Completion: May 30, 2021
• Study Completion: June 30, 2021
• Last Updated: October 14, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)