Spinal Cord InjuriesNCT04237363
Recovery of Walking in Persons With Complete Spinal Cord Injury
A study testing Exercise in people with Spinal Cord Injuries, run by Middle Tennessee State University.
Trial summary
We documented the impact of 1 year of underwater treadmill training and supplemental overground walk training in five adults with chronic motor-complete SCI (cSCI) who had not undergone programmed epidural spinal cord stimulation (eSCS). Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- No sites listed yet
- Study dates
- 5 Jul 2011to 6 Aug 2013
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- At least 21 years of age
- Presence of traumatic or non-traumatic spinal cord injury for at least 1 year
- Medical diagnosis of paraplegia (T1 or below)
Who cannot join
- Presence of complex comorbidities that could limit involvement in training activities
- Surgical implantation or removal of a medical device six months prior to training
- Skin breakdown
- Use of electrical implants to promote ambulation
About this study
Official title: Recovery of Walking Without Epidural Spinal Cord Stimulation in Adults With Complete Spinal Cord Injury
We documented the impact of 1 year of underwater treadmill training and supplemental overground walk training in five adults with chronic motor-complete SCI (cSCI) who had not undergone programmed epidural spinal cord stimulation (eSCS).
Read the detailed description
Regular exposure to self-initiated treadmill walking in water, a unique sensorimotor exercise setting that makes stepping movements easier to perform, may capitalize on the adaptability of the neuromuscular system and enhance locomotor function in persons with cSCI who have not undergone eSCS. In our study, a combined aquatics- and land-based approach to gait training was employed over a 12-month period that featured underwater treadmill training and supplemental overground walk training.
- Conditions
- Spinal Cord Injuries
- Being tested
- Exercise
- Keywords
- Spinal Cord Injury, Exercise, Walking, Aquatics
- Medical subject headings
- Spinal Cord Injuries, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseBehavioural
Underwater treadmill training and supplemental overground walk training
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Walk training Receives: Behavioral: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overground walking capacity
Walking Capacity for Spinal Cord Injury (WISCI-II)
Measured: Change from Baseline WISCI-II score at 6 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2020
- Study start5 Jul 2011
- Primary completion6 Aug 2013
- Study completion6 Aug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- 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
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Middle Tennessee State University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Don W Morgan, PhD, Study director, Middle Tennessee State UniversitySandra L Stevens, PhD, PT, Principal investigator, Middle Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04237363
- Sponsor's protocol ID
- 11-310
- Status last verified
- Jan 2020
- First submitted
- 15 Jan 2020
- Last updated
- 23 Jan 2020
- 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 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of Walking Without Epidural Spinal Cord Stimulation in Adults With Complete Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT04237363
- Acronym / sponsor ID
- 11-310
- Conditions
- Spinal Cord Injuries
- Keywords
- Spinal Cord Injury, Exercise, Walking, Aquatics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Middle Tennessee State UniversityUniversity, hospital or other
- Study start
- 5 Jul 2011 (actual)
- Primary completion
- 6 Aug 2013 (actual)
- Study completion
- 6 Aug 2013 (actual)
- First posted
- 23 Jan 2020 (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.
We documented the impact of 1 year of underwater treadmill training and supplemental overground walk training in five adults with chronic motor-complete SCI (cSCI) who had not undergone programmed epidural spinal cord stimulation (eSCS).
Detailed description
Regular exposure to self-initiated treadmill walking in water, a unique sensorimotor exercise setting that makes stepping movements easier to perform, may capitalize on the adaptability of the neuromuscular system and enhance locomotor function in persons with cSCI who have not undergone eSCS. In our study, a combined aquatics- and land-based approach to gait training was employed over a 12-month period that featured underwater treadmill training and supplemental overground walk training.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Behavioral: ExerciseWalk training |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 21 years of age
- Presence of traumatic or non-traumatic spinal cord injury for at least 1 year
- Medical diagnosis of paraplegia (T1 or below)
Key exclusion criteria (4 listed)
- Presence of complex comorbidities that could limit involvement in training activities
- Surgical implantation or removal of a medical device six months prior to training
- Skin breakdown
- Use of electrical implants to promote ambulation
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 |
|---|---|---|
| ExerciseUnderwater treadmill training and supplemental overground walk training | Behavioural | Exercise |
Primary outcome
Overground walking capacity
Time frame: Change from Baseline WISCI-II score at 6 months and 12 months
Walking Capacity for Spinal Cord Injury (WISCI-II)
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 23 Jan 2020.
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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.
Don W Morgan, PhD study director
Middle Tennessee State University
Sandra L Stevens, PhD, PT principal investigator
Middle Tennessee State University
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Spinal Cord Injuries, run by Middle Tennessee State University.
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 3 inclusion and 4 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 23 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Overground walking capacity (time frame: Change from Baseline WISCI-II score at 6 months and 12 months). 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 23 Jan 2020.