Clinical Trials Directory

Trials / Completed

CompletedNCT03817086

Physical and Mental Practice for Bimanual Coordination Rehabilitation

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
19 (actual)
Sponsor
Kessler Foundation · Academic / Other
Sex
All
Age
20 Years – 60 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALHand coordination and mental practice20 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).
BEHAVIORALHand coordination and action observationIn the control group 2, participants undergo 5 weeks (3 hrs/week) of physical training (PP group).

Timeline

Start date
2017-06-28
Primary completion
2021-05-30
Completion
2021-06-30
First posted
2019-01-25
Last updated
2022-10-14

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT03817086. Inclusion in this directory is not an endorsement.

Physical and Mental Practice for Bimanual Coordination Rehabilitation (NCT03817086) · Clinical Trials Directory