Spinal Cord InjuryNCT02498548
Training of Eccentric Lower Extremity Function After SCI
A study testing Trained SCI Knee or Trained SCI Hip in people with Spinal Cord Injury, run by Ohio State University at 1 site in United States.
Trial summary
This project will characterize lower extremity eccentric muscle function among individuals who have undergone locomotor training after spinal cord injury and will evaluate the effect of downhill training at moderate speeds - targeted to rehabilitation eccentric function of the knee or hip. Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Trained SCI Knee or Trained SCI Hip
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Oct 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 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- medically approved
- discharged from outpatient rehabilitation for 6 months
- incomplete SCI based on ASIA impairment score (AIS C or D) at neurologic level C1-T10
- ability to take some steps overground and on the treadmill
- 18-90 years old.
- ability to speak English. Note: the quality of life measures have not been validated yet in non-English speaking populations.
Who cannot join
- evidence of lower motor neuron injury in the legs
- use of botox in the past 3 months
- pre-existing or confounding neurologic conditions (i.e. brain injury, stroke, HIV)
- acute deep vein thrombosis
- skin wounds in regions where harness or hands provide support
- pregnancy. Note: Persons who are pregnant will not be enrolled as exercise tolerance is unknown in these women with SCI.
Show all 12Show fewer
- cognitive conditions that preclude providing informed consent
- ventilator-dependence as study results will be confounded by mobility limitations imposed by equipment
- persistent orthostatic hypotension (drop of BP >30mmHg in treadmill and harness equipment)
- hospitalization for myocardial infarction, cardiac surgery or congestive heart failure exacerbation within 3 months of enrollment in study
- participation in any other concurrent exercise programs.
- Note: Use of anti-spasticity and other medications (dose, frequency) will be monitored throughout training and used as a confounding variable in the analyses.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Intervention for Hip and Knee Function
This project will characterize lower extremity eccentric muscle function among individuals who have undergone locomotor training after spinal cord injury and will evaluate the effect of downhill training at moderate speeds - targeted to rehabilitation eccentric function of the knee or hip.
Read the detailed description
Lower extremity eccentric motor control is is critically important for locomotor function but is impaired after spinal cord injury (SCI). Even after treadmill training, preliminary evidence indicates that eccentric deficits persist among individuals with SCI. This proposal aims to characterize eccentric motor control of the muscles about the knee or hip during locomotion and evaluate the efficacy of downhill gait training at moderate speeds as an intervention to improve eccentric function of the knee joint or hip joint during walking.
- Conditions
- Spinal Cord Injury
- Being tested
- Trained SCI Knee or Trained SCI Hip
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trained SCI Knee or Trained SCI HipBehavioural
Also called DH Knee; DH Hip
Individuals with SCI will perform downhill walking training 3 times a week for 12 wks with a 4 wk follow-up period. This intervention will be delivered by trained therapists. In order to focus on rehabilitation of knee control or hip control, members of this group will be trained at slow to moderate gait speeds.
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Individuals with no spinal cord injury or other neurological deficits. |
| Unexercised SCI Knee or Hip | No intervention | Individuals with spinal cord injury who have been discharged from a locomotor training program at least 6 months prior to enrollment in this study. This group will serve as unexercised control for the "Trained SCI Knee" group or "trained SCI Hip" group |
| Trained SCI Knee or Trained SCI Hip | Experimental | Individuals with spinal cord injury who have been discharged from a locomotor training program at least 6 months prior to enrollment in this study. Training will specifically focus on rehabilitation of the knee joint or the hip joint. Receives: Behavioral: Trained SCI Knee or Trained SCI Hip |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)
Measured: baseline, 12 weeks
Secondary outcomes (2)
Change from baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)
Measured: baseline, 12 weeks
Change from baseline in peak magnitude of sagittal knee power absorption or frontal Hip power during loading response
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Notre Dame
- Responsible party
- Principal investigator, Michele Basso, Ohio State University
- Investigators
- D. Michele M Basso, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02498548
- Sponsor's protocol ID
- 2014H0386
- Status last verified
- Mar 2021
- First submitted
- 9 Jul 2015
- Last updated
- 19 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Eccentric Motor Control Training to Improve Human Spinal Cord Injury: Intervention for Hip and Knee Function
- ClinicalTrials.gov ID
- NCT02498548
- Acronym / sponsor ID
- 2014H0386
- Conditions
- Spinal Cord Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Collaborators
- University of Notre Dame
- Study start
- Jun 2015
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 15 Jul 2015 (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.
This project will characterize lower extremity eccentric muscle function among individuals who have undergone locomotor training after spinal cord injury and will evaluate the effect of downhill training at moderate speeds - targeted to rehabilitation eccentric function of the knee or hip.
Detailed description
Lower extremity eccentric motor control is is critically important for locomotor function but is impaired after spinal cord injury (SCI). Even after treadmill training, preliminary evidence indicates that eccentric deficits persist among individuals with SCI. This proposal aims to characterize eccentric motor control of the muscles about the knee or hip during locomotion and evaluate the efficacy of downhill gait training at moderate speeds as an intervention to improve eccentric function of the knee joint or hip joint during walking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Individuals with no spinal cord injury or other neurological deficits. |
| Unexercised SCI Knee or Hip | No intervention | –Individuals with spinal cord injury who have been discharged from a locomotor training program at least 6 months prior to enrollment in this study. This group will serve as unexercised control for the "Trained SCI Knee" group or "trained SCI Hip" group |
| Trained SCI Knee or Trained SCI Hip | Experimental | Behavioral: Trained SCI Knee or Trained SCI HipIndividuals with spinal cord injury who have been discharged from a locomotor training program at least 6 months prior to enrollment in this study. Training will specifically focus on rehabilitation of the knee joint or the hip joint. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- medically approved
- discharged from outpatient rehabilitation for 6 months
- incomplete SCI based on ASIA impairment score (AIS C or D) at neurologic level C1-T10
- ability to take some steps overground and on the treadmill
- 18-90 years old.
Key exclusion criteria (12 listed)
- evidence of lower motor neuron injury in the legs
- use of botox in the past 3 months
- pre-existing or confounding neurologic conditions (i.e. brain injury, stroke, HIV)
- acute deep vein thrombosis
- skin wounds in regions where harness or hands provide support
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 |
|---|---|---|
| Trained SCI Knee or Trained SCI HipAlso: DH Knee; DH HipIndividuals with SCI will perform downhill walking training 3 times a week for 12 wks with a 4 wk follow-up period. This intervention will be delivered by trained therapists. In order to focus on rehabilitation of knee control or hip control, members of this group will be trained at slow to moderate gait speeds. | Behavioural | Trained SCI Knee or Trained SCI Hip |
Primary outcome
Change from baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test)
Time frame: baseline, 12 weeks
2 secondary outcomes
Change from baseline in time to complete 10 meters of level walking (i.e., the 10 meter walk test)
Time frame: baseline, 12 weeks
Change from baseline in peak magnitude of sagittal knee power absorption or frontal Hip power during loading response
Time frame: baseline, 12 weeks
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 19 Mar 2021.
Related trials for Spinal Cord Injury
Recruiting
Comparison Between Objective Biomechanical Cost and Perceived Physical Demand in Manual Wheelchair Users During Propulsion Tasks
Manual Wheelchair Use, Spinal Cord Injury
Not yet recruitingObservational study
Risk Factors for Spinal Cord Injury After Minimally Invasive Aortic Repair
Spinal Cord Ischemia
Not yet recruiting
Feasibility of Transcutaneous Spinal Stimulation in Rehabilitation
Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI)
Recruiting
Evaluating Long-term Use of a Pediatric Robotic Exoskeleton (P.REX/Agilik) to Improve Gait in Children With Movement Disorders
Cerebral Palsy, Muscular Dystrophy
Not yet recruiting
Functional Electrical Stimulation Plus High Intensity Interval Training at Home
Spinal Cord Injuries (SCI)
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.
D. Michele M Basso principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Trained SCI Knee or Trained SCI Hip in people with Spinal Cord Injury, run by Ohio State 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 6 inclusion and 12 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 19 Mar 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. 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 from baseline in time to complete 6 minutes of level walking (i.e., the 6 minute walk test) (time frame: baseline, 12 weeks). 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 19 Mar 2021.