Traumatic Brain InjuryNCT03817086
Physical and Mental Practice for Bimanual Coordination Rehabilitation
A study testing Hand coordination and mental practice and Hand coordination and action observation in people with Traumatic Brain Injury and Weakness, Muscle, run by Kessler Foundation at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Traumatic Brain Injury, Weakness, Muscle, Coordination Impairment
- What is being tested?
- Hand coordination and mental practice and Hand coordination and action observation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jun 2017to 30 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Combining Physical and Mental Practice for the Rehabilitation of Upper Extremity Movement Impairments Secondary to Traumatic Brain Injury
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.
Read the 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.
- Being tested
- Hand coordination and mental practice, Hand coordination and action observation
- Medical subject headings
- Brain Injuries, Traumatic, Muscle Weakness, Ataxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hand coordination and mental practiceBehavioural
Also called experimental group
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 observationBehavioural
Also called control group
In the control group 2, participants undergo 5 weeks (3 hrs/week) of physical training (PP group).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Hand coordination and action observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximum voluntary contraction
maximum force exerted by each hand during squeezing a handgrip force sensor
Measured: 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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Pretest (before training), Posttest (immediately after end of training)
Change in resting state function connectivity
connectivity between sensorimotor and attention network at rest
Measured: Pretest (before training), Posttest (immediately after end of training)
Change in brain structural connectivity (DTI)
cerebrospinal tract connectivity
Measured: Pretest (before training), Posttest (immediately after end of training)
Secondary outcomes (2)
stroop effect test
neuropsychology assessments of reaction time
Measured: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
trail making test
neuropsychology assessments of task switching and visual attention
Measured: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2019
- Study start28 Jun 2017
- Primary completion30 May 2021
- Study completion30 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Kessler FoundationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Soha Saleh, PhD, Principal investigator, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03817086
- Sponsor's protocol ID
- R970-17
- Status last verified
- Oct 2022
- First submitted
- 10 Jan 2019
- Last updated
- 14 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combining Physical and Mental Practice for the Rehabilitation of Upper Extremity Movement Impairments Secondary to Traumatic Brain Injury
- ClinicalTrials.gov ID
- NCT03817086
- Acronym / sponsor ID
- R970-17
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Study start
- 28 Jun 2017 (actual)
- Primary completion
- 30 May 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 25 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hand coordination and mental practice | Experimental | Behavioral: Hand coordination and mental practiceIn 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. |
| Hand coordination and action observation | Active comparator | Behavioral: Hand coordination and action observationIn 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. |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hand coordination and mental practiceAlso: experimental group20 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). | Behavioural | Hand coordination and mental practice |
| Hand coordination and action observationAlso: control groupIn the control group 2, participants undergo 5 weeks (3 hrs/week) of physical training (PP group). | Behavioural | Hand coordination and action observation |
Primary outcome
Change in Maximum voluntary contraction
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
Change in Reaction Time
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.
Change in Percent of Error in force matching
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.
Change in wolf motor function test
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (4 weeks after end of training)
assessment of upper extremity function
Change in within-brain effective connectivity
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
Change in resting state function connectivity
Time frame: Pretest (before training), Posttest (immediately after end of training)
connectivity between sensorimotor and attention network at rest
Change in brain structural connectivity (DTI)
Time frame: Pretest (before training), Posttest (immediately after end of training)
cerebrospinal tract connectivity
2 secondary outcomes
stroop effect test
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
trail making test
Time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soha Saleh, PhD principal investigator
Kessler Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hand coordination and mental practice and Hand coordination and action observation in people with Traumatic Brain Injury and Weakness, Muscle, run by Kessler Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Maximum voluntary contraction (time frame: Pretest (before training), Posttest (immediately after end of training), Retention test (3 weeks after end of training)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2022.