Kessler Foundation
West Orange, New Jersey, 07052, United States
NCT Number: NCT03817086
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.
Looking for future studies?
Notify Me20 year–60 year
All sexes
Interventional
Not applicable
West Orange, New Jersey, 07052, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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).
Other names: experimental group
In the control group 2, participants undergo 5 weeks (3 hrs/week) of physical training (PP group).
Other names: control group
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
maximum force exerted by each hand during squeezing a handgrip force sensor
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
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
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: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
assessment of upper extremity function
Time frame: Pretest (before training), Posttest (immediately after end of training)
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)
connectivity between sensorimotor and attention network at rest
Time frame: Pretest (before training), Posttest (immediately after end of training)
cerebrospinal tract connectivity
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
neuropsychology assessments of reaction time
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
neuropsychology assessments of task switching and visual attention
Kessler Foundation
Other
Combining Physical and Mental Practice for the Rehabilitation of Upper Extremity Movement Impairments Secondary to Traumatic Brain Injury
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05945784
Amyotrophic Lateral Sclerosis, Autoimmune Diseases
Pomona, California, United States
View Trial DetailsNCT01287156
Brain Diseases, Brain Injuries
Washington D.C., District of Columbia, United States
View Trial DetailsNCT05714150
Brain Diseases, Brain Injuries
Gainesville, Florida, United States
View Trial DetailsNCT04056312
Brain Diseases, Brain Injuries
West Orange, New Jersey, United States
View Trial Details