Motor Learning in TBINCT02236676
Sleep Study Among Inpatients With TBI in an Acute Rehabilitation Hospital
A study testing Nap after rehearsal trials in people with Motor Learning in TBI, run by Kessler Foundation at 1 site in United States.
Trial summary
The purpose of this research study is to better understand how a daytime nap after training on a motor skill after brain injury improves performance compared with the same amount of time after training spent awake and resting. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Motor Learning in TBI
- What is being tested?
- Nap after rehearsal trials
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 28 May 2014to 31 May 2019
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Must have a Traumatic Brain Injury.
- Must have been a Kessler Institute for Rehabilitation inpatient for at least three days.
Who cannot join
- Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of the WatchPAT-200/actigragh.
- Movement disorder or spasticity affecting both upper extremities
- Patients who are ventilator-dependent.
- Patients who are on contact precautions for C.diff or other highly contagious diseases.
- Patients with neurological disorders other than TBI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sleep, Procedural Learning & Therapeutic Engagement Among Inpatients With
The purpose of this research study is to better understand how a daytime nap after training on a motor skill after brain injury improves performance compared with the same amount of time after training spent awake and resting.
- Conditions
- Motor Learning in TBI
- Being tested
- Nap after rehearsal trials
- Keywords
- motor learning TBI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nap after rehearsal trialsBehavioural
Behavioral
| Study group | Role | What they receive |
|---|---|---|
| Nap after rehearsal trials | Active comparator | A 30-minute daytime nap after training Receives: Behavioral: Nap after rehearsal trials |
| Resting while awake | Placebo comparator | Placebo condition of 30 minutes between training and retesting in which the half hour is spent resting awake in bed. Receives: Behavioral: Nap after rehearsal trials |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement on Motor Functioning Test
Change scores from day 1 to day 3 will be compared in both Nap and No Nap conditions
Measured: Three Nights and Three Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study start28 May 2014
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Motor Learning in TBIStudies 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
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kessler Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- New Jersey Commission on Brain Injury Research
- Responsible party
- Principal investigator, Anthony Lequerica, Kessler Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236676
- Sponsor's protocol ID
- R-833-14
- Status last verified
- Aug 2021
- First submitted
- 8 Sep 2014
- Last updated
- 5 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep, Procedural Learning & Therapeutic Engagement Among Inpatients With
- ClinicalTrials.gov ID
- NCT02236676
- Acronym / sponsor ID
- R-833-14
- Conditions
- Motor Learning in TBI
- Keywords
- motor learning TBI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Kessler FoundationUniversity, hospital or other
- Collaborators
- New Jersey Commission on Brain Injury Research
- Study start
- 28 May 2014 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 10 Sep 2014 (estimated)
- 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.
The purpose of this research study is to better understand how a daytime nap after training on a motor skill after brain injury improves performance compared with the same amount of time after training spent awake and resting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nap after rehearsal trials | Active comparator | Behavioral: Nap after rehearsal trialsA 30-minute daytime nap after training |
| Resting while awake | Placebo comparator | Behavioral: Nap after rehearsal trialsPlacebo condition of 30 minutes between training and retesting in which the half hour is spent resting awake in bed. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Must have a Traumatic Brain Injury.
- Must have been a Kessler Institute for Rehabilitation inpatient for at least three days.
Key exclusion criteria (5 listed)
- Bilateral arm fractures, cellulitis or other conditions that prevent safe wearing of the WatchPAT-200/actigragh.
- Movement disorder or spasticity affecting both upper extremities
- Patients who are ventilator-dependent.
- Patients who are on contact precautions for C.diff or other highly contagious diseases.
- Patients with neurological disorders other than TBI.
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 |
|---|---|---|
| Nap after rehearsal trialsBehavioral | Behavioural | Nap after rehearsal trials, Resting while awake |
Primary outcome
Improvement on Motor Functioning Test
Time frame: Three Nights and Three Days
Change scores from day 1 to day 3 will be compared in both Nap and No Nap conditions
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 5 Sep 2021.
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Recruiting
SeeMe: Using Automated Facial Tracking to Detect Voluntary Behavior in Brain Injury
Traumatic Brain Injury (TBI) Patients, Severe Traumatic Brain Injury
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nap after rehearsal trials in people with Motor Learning in TBI, 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 2 inclusion and 5 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 5 Sep 2021. 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. Some participants in this study may receive a placebo. 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?
Improvement on Motor Functioning Test (time frame: Three Nights and Three Days). 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 5 Sep 2021.