TBI (Traumatic Brain Injury)NCT03438409
Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
A study testing Robotic gait training in people with TBI (Traumatic Brain Injury), run by Indiana University at 1 site in United States.
Trial summary
The purpose of this study is to investigate changes in response to robotic gait training in individuals with a traumatic brain injury. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- TBI (Traumatic Brain Injury)
- What is being tested?
- Robotic gait training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2017to 30 Jul 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years of age
- traumatic brain injury at least 6 months prior to study
Who cannot join
- currently receiving outpatient therapy
- medically unstable
- body weight > 150 kgs
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to investigate changes in response to robotic gait training in individuals with a traumatic brain injury.
- Conditions
- TBI (Traumatic Brain Injury)
- Being tested
- Robotic gait training
- Medical subject headings
- Brain Injuries, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic gait trainingOther
Robotic gait training
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Study | Experimental | This study has a single arm with repeated baseline measures. This arm will complete the robotic gait training. Receives: Other: Robotic gait training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Functional Gait Outcomes
Gait speed will be assessed using a gait mat.
Measured: Change from baseline gait speed to post-test up to 6 weeks following the intervention.
Change in Endurance
Endurance will be assessed using the 6-minute walk test.
Measured: Change from baseline distance covered to post-test up to 6 weeks following the intervention.
Secondary outcomes (1)
Change in balance
Balance will be assessed using the Berg Balance Scale.
Measured: Change from baseline balance to post-test up to 6 weeks following the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Feb 2018
- Study start1 Jul 2017
- Primary completion30 Jul 2018
- Study completion30 Jul 2018
Why it stopped: Changes in personnel at Institution.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TBI (Traumatic Brain Injury)Studies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Crystal Massie, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03438409
- Sponsor's protocol ID
- 1703719961
- Status last verified
- Dec 2018
- First submitted
- 4 Aug 2017
- Last updated
- 6 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Improving Functional Ability in Chronic TBI With Intensive Rehabilitation Robotic Gait Training
- ClinicalTrials.gov ID
- NCT03438409
- Acronym / sponsor ID
- 1703719961
- Conditions
- TBI (Traumatic Brain Injury)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Changes in personnel at Institution.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 30 Jul 2018 (actual)
- Study completion
- 30 Jul 2018 (actual)
- First posted
- 19 Feb 2018 (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.
The purpose of this study is to investigate changes in response to robotic gait training in individuals with a traumatic brain injury.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single Arm Study | Experimental | Other: Robotic gait trainingThis study has a single arm with repeated baseline measures. This arm will complete the robotic gait training. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18 years of age
- traumatic brain injury at least 6 months prior to study
Key exclusion criteria (3 listed)
- currently receiving outpatient therapy
- medically unstable
- body weight > 150 kgs
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 |
|---|---|---|
| Robotic gait trainingRobotic gait training | Other | Single Arm Study |
Primary outcome
Change in Functional Gait Outcomes
Time frame: Change from baseline gait speed to post-test up to 6 weeks following the intervention.
Gait speed will be assessed using a gait mat.
Change in Endurance
Time frame: Change from baseline distance covered to post-test up to 6 weeks following the intervention.
Endurance will be assessed using the 6-minute walk test.
1 secondary outcome
Change in balance
Time frame: Change from baseline balance to post-test up to 6 weeks following the intervention.
Results and safety
The study was stopped early (reason given: Changes in personnel at Institution.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2018.
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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.
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 Robotic gait training in people with TBI (Traumatic Brain Injury), run by Indiana University 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 3 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: stopped early, as of the sponsor's last update on 6 Dec 2018. 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 was stopped early (reason given: Changes in personnel at Institution.). Results are not available in the source record.
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 Functional Gait Outcomes (time frame: Change from baseline gait speed to post-test up to 6 weeks following the intervention.). The study lists 2 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 6 Dec 2018.