Motor-incomplete Spinal Cord InjuryNCT00610974
Enhancing Walking in People With Incomplete Spinal Cord Injury: a Pilot Study
A study testing Body-weight supported treadmill training in people with Motor-incomplete Spinal Cord Injury, run by University of British Columbia at 1 site in Canada.
Trial summary
The research proposed here will determine the effect of a novel treadmill gait training strategy using a robotic gait trainer (the Lokomat) on functional ambulation in people with SCI. The effect of the new therapy will be evaluated by analyzing changes in functional ambulation and gait patterns during walking. Read more about this study
- Who is it for?
- Ages 19 to 65 years
- Conditions the study is for
- Motor-incomplete Spinal Cord Injury
- What is being tested?
- Body-weight supported treadmill training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Mar 2008to Jul 2011
- 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 19 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- motor-incomplete SCI due to non-progressive lesion (e.g. trauma, ischemia) at least 12 months ago
- 19 to 65 years of age
- use of standing or walking as part of typical activities of daily living
- controlled spasticity (stable administration of anti-spasticity medication) for the duration of the study
Who cannot join
- lesion below 11th thoracic level (lower motoneuron injury)
- weight greater than 300 lbs or height greater than 6'1"
- femur length <35 cm or >47 cm and body weight >150 kg
- cardiac, musculoskeletal, or other uncontrolled health condition (e.g. orthostatic hypotension, osteoporosis) for which exercise or treadmill activity is contra-indicated
- existing skin irritation or open wounds/sores in lower extremity areas in contact with the leg cuffs of the Lokomat or body weight support harness
- existing cognitive impairment (as indicated by a Cognitive Capacity Screening Examination (CCSE) score of less than 24 out of 30)
- participation in rehabilitation therapy or other research study with exercise or mobility outcomes
Trial locations and contacts
1 site in 1 country.
Canada1 site
Human Locomotion Lab, University of British Columbia
Vancouver, British Columbia, V6T 1Z3
About this study
Official title: Enhancing Walking in People With Incomplete Spinal Cord Injury by Improving Swing Phase Activity: a Pilot Study
The research proposed here will determine the effect of a novel treadmill gait training strategy using a robotic gait trainer (the Lokomat) on functional ambulation in people with SCI. The effect of the new therapy will be evaluated by analyzing changes in functional ambulation and gait patterns during walking.
Read the detailed description
Community-dwelling individuals with motor-incomplete spinal cord injury will be recruited. In total, 20 participants will be recruited and randomly assigned to one of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to the leg movements while walking. Therapy for both groups will take place 3 times/week for 12 weeks. During each session, participants will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but participants should complete 45 minutes of walking per session.
- Conditions
- Motor-incomplete Spinal Cord Injury
- Being tested
- Body-weight supported treadmill training
- Keywords
- Spinal cord injury, walking, gait training, body-weight supported treadmill training, rehabilitation
- 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.
Body-weight supported treadmill trainingBehavioural
BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.
Body-weight supported treadmill trainingBehavioural
BWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | One of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking. Receives: Behavioral: Body-weight supported treadmill training |
| 2 | Experimental | One of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking. Receives: Behavioral: Body-weight supported treadmill training |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training.
Measured: 6 months
Secondary outcomes (1)
Average activity level per day measured before, after, 1-month after, and 6-months after training
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2008 (estimated)
- Study startMar 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Motor-incomplete Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Care provider
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Tania Lam, Ph.D, Principal investigator, University of British ColumbiaJanice J. Eng, Ph.D, Study director, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610974
- Sponsor's protocol ID
- H07-01394
- Status last verified
- Sep 2014
- First submitted
- 28 Jan 2008
- Last updated
- 25 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Lam T, Pauhl K, Ferguson A, Malik RN; BKin; Krassioukov A, Eng JJ. Training with robot-applied resistance in people with motor-incomplete spinal cord injury: Pilot study. J Rehabil Res Dev. 2015;52(1):113-29. doi: 10.1682/JRRD.2014.03.0090.
PubMed 26230667
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Walking in People With Incomplete Spinal Cord Injury by Improving Swing Phase Activity: a Pilot Study
- ClinicalTrials.gov ID
- NCT00610974
- Acronym / sponsor ID
- H07-01394
- Conditions
- Motor-incomplete Spinal Cord Injury
- Keywords
- Spinal cord injury, walking, gait training, body-weight supported treadmill training, rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 8 Feb 2008 (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 research proposed here will determine the effect of a novel treadmill gait training strategy using a robotic gait trainer (the Lokomat) on functional ambulation in people with SCI. The effect of the new therapy will be evaluated by analyzing changes in functional ambulation and gait patterns during walking.
Detailed description
Community-dwelling individuals with motor-incomplete spinal cord injury will be recruited. In total, 20 participants will be recruited and randomly assigned to one of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to the leg movements while walking. Therapy for both groups will take place 3 times/week for 12 weeks. During each session, participants will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but participants should complete 45 minutes of walking per session.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Behavioral: Body-weight supported treadmill trainingOne of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking. |
| 2 | Experimental | Behavioral: Body-weight supported treadmill trainingOne of 2 types of body-weight supported treadmill training (BWSTT) with the Lokomat, which differ only in the level of assistance that the Lokomat provides to leg movements while walking. |
Who may qualify
- Ages
- 19 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- motor-incomplete SCI due to non-progressive lesion (e.g. trauma, ischemia) at least 12 months ago
- 19 to 65 years of age
- use of standing or walking as part of typical activities of daily living
- controlled spasticity (stable administration of anti-spasticity medication) for the duration of the study
Key exclusion criteria (7 listed)
- lesion below 11th thoracic level (lower motoneuron injury)
- weight greater than 300 lbs or height greater than 6'1"
- femur length <35 cm or >47 cm and body weight >150 kg
- cardiac, musculoskeletal, or other uncontrolled health condition (e.g. orthostatic hypotension, osteoporosis) for which exercise or treadmill activity is contra-indicated
- existing skin irritation or open wounds/sores in lower extremity areas in contact with the leg cuffs of the Lokomat or body weight support harness
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 |
|---|---|---|
| Body-weight supported treadmill trainingBWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session. | Behavioural | 1 |
| Body-weight supported treadmill trainingBWSTT for 3 times/week for 12 weeks. Each session, subjects will first complete a 10-minute warm-up period followed by 45 minutes of the assigned therapy. Rest breaks will be provided as needed, but subjects must complete 45 minutes of walking per session. | Behavioural | 2 |
Primary outcome
The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training.
Time frame: 6 months
1 secondary outcome
Average activity level per day measured before, after, 1-month after, and 6-months after training
Time frame: 6 months
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 25 Sep 2014.
- Derived from this study: PubMed 26230667Lam T, Pauhl K, Ferguson A, Malik RN; BKin; Krassioukov A, Eng JJ. Training with robot-applied resistance in people with motor-incomplete spinal cord injury: Pilot study. J Rehabil Res Dev. 2015;52(1):113-29. doi: 10.1682/JRRD.2014.03.0090.
Related trials for Motor-incomplete Spinal Cord Injury
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Active, not recruiting
EKSO Trial: Powered Exoskeleton for Ambulation in Subjects With Spinal Cord Injury (SCI)
Spinal Cord Injuries or Similar Neurological Weakness
Recruiting
ZEPU-2000 Limb Rehabilitation Trainer Study (ZEPU2000RCT)
Stroke, Incomplete Spinal Cord Injury (SCI)
Recruiting
ZEPU-SGI1PLUS Hand Training Study (ZEPUSGI1RCT)
Upper Limb Motor Dysfunction, Stroke
Recruiting
ZEPU AI9 Exoskeleton Rehabilitation Robot
Stroke, Gait Disorders, Neurologic
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.
Tania Lam, Ph.D principal investigator
University of British Columbia
Janice J. Eng, Ph.D study director
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Body-weight supported treadmill training in people with Motor-incomplete Spinal Cord Injury, run by University of British Columbia at 1 site in Canada.
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 4 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 25 Sep 2014. 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 Canada. 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?
The primary outcome is functional ambulation measured before, after, 1-month after, and 6-months after training. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00610974, which also lists 1 linked publication.
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 25 Sep 2014.