Spinal Cord InjuriesNCT02960178
Reactive Stepping Training in Individuals With Spinal Cord Injury
A study testing Perturbation-based training and Conventional walking training in people with Spinal Cord Injuries, run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Falling is common among individuals with incomplete spinal cord injury (iSCI), with most falls occurring while walking. Falls result in injuries (e.g., broken bones), hospital readmission, and reduced participation in work and recreation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Perturbation-based training and Conventional walking training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2017to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- individuals with SCI rated as C or D on the American Spinal Injury Association Impairment Scale (AIS)
- chronic SCI (i.e., >1 year post-injury)
- a traumatic or non-traumatic and non-progressive cause of SCI
- ≥18 years old
- able to stand for 30s unsupported
- moderate level of trunk control as evidenced by the ability to reach forward >2 inches with the outstretched arm in standing (i.e., score of 2 on Berg Balance Scale Reaching Forward Task
- free of any other condition besides SCI that significantly affects walking or balance (e.g., no vestibular disorder, significant vision loss, stroke)
- no known, untreated orthostatic hypotension, hypertension, or atrial/ventricular arrhythmia
Who cannot join
- severe spasticity in the legs
- contractures in the lower extremity that prevent achieving a neutral hip and ankle position, or extended knee
- a pressure sore (>grade 2) on the pelvis or trunk where the harness will be applied
- a prior lower extremity fragility fracture.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Lyndhurst Centre, Toronto Rehabilitation Institute-UHN
Toronto, Ontario, M4G 3V9
About this study
Official title: Assessment and Training of Reactive Stepping in Individuals With Spinal Cord Injury
Falling is common among individuals with incomplete spinal cord injury (iSCI), with most falls occurring while walking. Falls result in injuries (e.g., broken bones), hospital readmission, and reduced participation in work and recreation. In able-bodied people, falls can be prevented by taking one or more rapid, reactive steps. People with iSCI, however, have difficulty taking the reactive steps needed to prevent a fall. Research in the elderly and people with stroke has shown that repetitive training of reactive steps in a safe environment improves this balance reaction and prevents falls. The investigators will examine the feasibility and effectiveness of reactive step training in people with iSCI. The main objective is to determine if reactive balance training leads to greater improvements in balance reactions, scores on clinical scales, and fall rates compared with conventional walking training. A three year, pilot randomized clinical trial (RCT) will be completed. By improving balance and reducing falls, people with iSCI will experience fewer complications (e.g., injuries), and greater recovery of function and community participation.
Read the detailed description
The research aim is to determine if perturbation-based training (PBT) leads to greater improvements in balance reactions, scores on clinical scales, and fall rates compared with conventional gait training. The investigators hypothesize that individuals with iSCI who participate in PBT will show significantly greater gains in: 1) the ability to take a reactive step during the lean-and-release test, as evidenced by a reduction in both the time taken to initiate the reaction, and the number of steps taken to regain balance; and 2) clinical measures of gait, balance, and balance self-efficacy. The investigators also hypothesize that individuals who participate in PBT will experience fewer falls in the 6 months following training than the conventional training group.
All 24 participants with iSCI will complete 2 baseline assessments spaced 2 weeks apart. The participants will then be randomized into perturbation-based training and conventional gait training (12 participants/group) using a matched pairs design. Participants will be matched based on AIS level (C or D) and age (<60 years or >60 years). For both programs, the dosage will be 3 sessions/week for 8 weeks, with each session lasting 1 hour. After training, follow-up assessments, including the lean-and-release test and clinical measures, will be completed at 3 and 6 months post-training. PBT and conventional gait training will be delivered by a graduate student with a background in Physical Therapy or Kinesiology and supervised by a licensed physical therapist. PBT will consist of repetitive practice of reactive stepping for 1 hour. Participants will experience 60 perturbations per session during standing and walking activities, such as standing on a compliant surface or with eyes closed, stepping on targets on the ground, or stepping sideways. To create a perturbation, the researcher will apply unexpected pushes or pulls to a safety harness around the participant's trunk. The perturbation will be sufficient in magnitude to elicit a stepping response from the participant. Conventional training will consist of treadmill (0.5 hr) and over-ground (0.5 hr) gait training. On the treadmill, participants will walk as fast and as long as possible. Body weight-support may be used, if needed. During over-ground walking, participants will practice similar activities to the PBT group, but no perturbations will be applied. After the training period, participants will be followed for 6 months to track the occurrence and consequences of falls. If a participant experiences a fall, he/she will be asked to complete a short survey (online or on paper) within 24 hours of falling. A researcher will maintain monthly contact with participants to ensure falls are documented. Assessments will be performed twice during the baseline period, and after 4 and 8 weeks of training, and 3 and 6 months post-training for those participating in the RCT. The lean-and-release test will be administered by the research team due to the technical expertise required. All other measures will be administered by licensed PTs who are blind to study purpose and training allocation. The lean-and-release test will quantify the ability to take reactive steps. Participants will stand on a force plate and lean forward with 5-10% of their body weight supported by a horizontal cable. The cable is released at an unpredictable time, and participants must take a reactive step forward onto a second force plate. Ground reaction forces and surface electromyography of the legs (rectus femoris, vastus lateralis, biceps femoris, soleus, medial gastrocnemius, and tibialis anterior) will be recorded. The lean-and-release test has good test-retest reliability in older adults. The Mini-Balance Evaluation System's Test assesses four balance control systems, including postural responses to perturbations. This scale has been used in SCI, and has shown good validity and reliability in stroke and Parkinson's disease. The Activities-specific Balance Confidence Scale is a questionnaire on balance self-efficacy. Participants rate their confidence in their ability to maintain balance while performing 16 functional tasks. It has been used in individuals with SCI and has good psychometric properties in stroke. Spatio-temporal gait parameters, such as step width and double support time, will be collected with the Zeno Walkway (ProtoKinetics).
All electromyography (EMG), force plate and motion capture data will be sampled at 1 kHz. The EMG signals will amplified and bandpass filtered between 20-500Hz. EMG and force plate signals will be used to determine the timing of the reactive step, elicited by the lean-and-release test. The magnitude of activity in each muscle during the reactive step will evaluated using the root mean square of each muscle's EMG. The Shapiro-Wilk test will be used to test the assumption of normality. To compare the outcomes of the 2 training programs, a one-way repeated measures ANOVA or Friedman's Test will be used. The alpha level will be set at 0.05.
- Conditions
- Spinal Cord Injuries
- Being tested
- Perturbation-based training, Conventional walking training
- 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.
Perturbation-based trainingBehavioural
Over-ground practice of stepping and balance tasks in standing with perturbations applied by the trainer (pushes and pulls to the safety harness). One hour in duration with 60 perturbations targeted per hour.
Conventional walking trainingBehavioural
Over-ground practice of stepping and balance tasks in standing. One hour in duration.
| Study group | Role | What they receive |
|---|---|---|
| Perturbation-based training | Experimental | Participants will practice standing and walking activities while secured in an overhead harness attached to an overhead track. While practicing these tasks, the trainer will apply pushes and pulls to the harness at unexpected times, causing a reactive step to be practiced. Receives: Behavioral: Perturbation-based training |
| Conventional walking training | Active comparator | Participants will practice standing and walking activities while secured in an overhead harness attached to an overhead track. No external perturbations will be applied. Receives: Behavioral: Conventional walking training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in reactive stepping ability (Lean and Release Test)
Inness EL, Mansfield A, Biasin L, et al. Clinical implementation of a reactive balance control assessment in a sub-acute stroke patient population using a 'lean-and-release' methodology. Gait \& Posture 2015; 41: 529-34.
Measured: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
Secondary outcomes (5)
Change in the Mini-BESTest score
Clinical measure of balance
Measured: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
Change in the Activities-specific Balance Confidence Scale score
Questionnaire
Measured: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
Change in the Community Balance & Mobility Scale
Clinical measure of balance
Measured: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
Change in spatiotemporal measures of gait
Zeno walkway
Measured: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
Change in the Falls Efficacy Scale - International score
Questionnaire
Measured: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2016 (estimated)
- Study startJan 2017
- Primary completionDec 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Responsible party
- Principal investigator, Kristin Musselman, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02960178
- Sponsor's protocol ID
- 16-5685-DE
- Status last verified
- Mar 2020
- First submitted
- 3 Nov 2016
- Last updated
- 24 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Heffernan MG, Lee JW, Chan K, Unger J, Marzolini S, Welsh TN, Masani K, Musselman KE. Spatial characteristics of reactive stepping among people living with chronic incomplete spinal cord injury. J Spinal Cord Med. 2023 Sep;46(5):769-777. doi: 10.1080/10790268.2023.2175575. Epub 2023 Apr 10.
PubMed 37037014Unger J, Chan K, Lee JW, Craven BC, Mansfield A, Alavinia M, Masani K, Musselman KE. The Effect of Perturbation-Based Balance Training and Conventional Intensive Balance Training on Reactive Stepping Ability in Individuals With Incomplete Spinal Cord Injury or Disease: A Randomized Clinical Trial. Front Neurol. 2021 Feb 2;12:620367. doi: 10.3389/fneur.2021.620367. eCollection 2021.
PubMed 33603710Unger J, Oates AR, Lanovaz J, Chan K, Lee JW, Theventhiran P, Masani K, Musselman KE. The measurement properties of the Lean-and-Release test in people with incomplete spinal cord injury or disease. J Spinal Cord Med. 2022 May;45(3):426-435. doi: 10.1080/10790268.2020.1847562. Epub 2020 Dec 2.
PubMed 33263499
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment and Training of Reactive Stepping in Individuals With Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT02960178
- Acronym / sponsor ID
- 16-5685-DE
- Conditions
- Spinal Cord Injuries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Collaborators
- Ontario Neurotrauma Foundation
- Study start
- Jan 2017 (actual)
- Primary completion
- Dec 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 9 Nov 2016 (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.
Falling is common among individuals with incomplete spinal cord injury (iSCI), with most falls occurring while walking. Falls result in injuries (e.g., broken bones), hospital readmission, and reduced participation in work and recreation. In able-bodied people, falls can be prevented by taking one or more rapid, reactive steps. People with iSCI, however, have difficulty taking the reactive steps needed to prevent a fall. Research in the elderly and people with stroke has shown that repetitive training of reactive steps in a safe environment improves this balance reaction and prevents falls. The investigators will examine the feasibility and effectiveness of reactive step training in people with iSCI. The main objective is to determine if reactive balance training leads to greater improvements in balance reactions, scores on clinical scales, and fall rates compared with conventional walking training. A three year, pilot randomized clinical trial (RCT) will be completed. By improving balance and reducing falls, people with iSCI will experience fewer complications (e.g., injuries), and greater recovery of function and community participation.
Detailed description
The research aim is to determine if perturbation-based training (PBT) leads to greater improvements in balance reactions, scores on clinical scales, and fall rates compared with conventional gait training. The investigators hypothesize that individuals with iSCI who participate in PBT will show significantly greater gains in: 1) the ability to take a reactive step during the lean-and-release test, as evidenced by a reduction in both the time taken to initiate the reaction, and the number of steps taken to regain balance; and 2) clinical measures of gait, balance, and balance self-efficacy. The investigators also hypothesize that individuals who participate in PBT will experience fewer falls in the 6 months following training than the conventional training group.
All 24 participants with iSCI will complete 2 baseline assessments spaced 2 weeks apart. The participants will then be randomized into perturbation-based training and conventional gait training (12 participants/group) using a matched pairs design. Participants will be matched based on AIS level (C or D) and age (<60 years or >60 years). For both programs, the dosage will be 3 sessions/week for 8 weeks, with each session lasting 1 hour. After training, follow-up assessments, including the lean-and-release test and clinical measures, will be completed at 3 and 6 months post-training. PBT and conventional gait training will be delivered by a graduate student with a background in Physical Therapy or Kinesiology and supervised by a licensed physical therapist. PBT will consist of repetitive practice of reactive stepping for 1 hour. Participants will experience 60 perturbations per session during standing and walking activities, such as standing on a compliant surface or with eyes closed, stepping on targets on the ground, or stepping sideways. To create a perturbation, the researcher will apply unexpected pushes or pulls to a safety harness around the participant's trunk. The perturbation will be sufficient in magnitude to elicit a stepping response from the participant. Conventional training will consist of treadmill (0.5 hr) and over-ground (0.5 hr) gait training. On the treadmill, participants will walk as fast and as long as possible. Body weight-support may be used, if needed. During over-ground walking, participants will practice similar activities to the PBT group, but no perturbations will be applied. After the training period, participants will be followed for 6 months to track the occurrence and consequences of falls. If a participant experiences a fall, he/she will be asked to complete a short survey (online or on paper) within 24 hours of falling. A researcher will maintain monthly contact with participants to ensure falls are documented. Assessments will be performed twice during the baseline period, and after 4 and 8 weeks of training, and 3 and 6 months post-training for those participating in the RCT. The lean-and-release test will be administered by the research team due to the technical expertise required. All other measures will be administered by licensed PTs who are blind to study purpose and training allocation. The lean-and-release test will quantify the ability to take reactive steps. Participants will stand on a force plate and lean forward with 5-10% of their body weight supported by a horizontal cable. The cable is released at an unpredictable time, and participants must take a reactive step forward onto a second force plate. Ground reaction forces and surface electromyography of the legs (rectus femoris, vastus lateralis, biceps femoris, soleus, medial gastrocnemius, and tibialis anterior) will be recorded. The lean-and-release test has good test-retest reliability in older adults. The Mini-Balance Evaluation System's Test assesses four balance control systems, including postural responses to perturbations. This scale has been used in SCI, and has shown good validity and reliability in stroke and Parkinson's disease. The Activities-specific Balance Confidence Scale is a questionnaire on balance self-efficacy. Participants rate their confidence in their ability to maintain balance while performing 16 functional tasks. It has been used in individuals with SCI and has good psychometric properties in stroke. Spatio-temporal gait parameters, such as step width and double support time, will be collected with the Zeno Walkway (ProtoKinetics).
All electromyography (EMG), force plate and motion capture data will be sampled at 1 kHz. The EMG signals will amplified and bandpass filtered between 20-500Hz. EMG and force plate signals will be used to determine the timing of the reactive step, elicited by the lean-and-release test. The magnitude of activity in each muscle during the reactive step will evaluated using the root mean square of each muscle's EMG. The Shapiro-Wilk test will be used to test the assumption of normality. To compare the outcomes of the 2 training programs, a one-way repeated measures ANOVA or Friedman's Test will be used. The alpha level will be set at 0.05.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Perturbation-based training | Experimental | Behavioral: Perturbation-based trainingParticipants will practice standing and walking activities while secured in an overhead harness attached to an overhead track. While practicing these tasks, the trainer will apply pushes and pulls to the harness at unexpected times, causing a reactive step to be practiced. |
| Conventional walking training | Active comparator | Behavioral: Conventional walking trainingParticipants will practice standing and walking activities while secured in an overhead harness attached to an overhead track. No external perturbations will be applied. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- individuals with SCI rated as C or D on the American Spinal Injury Association Impairment Scale (AIS)
- chronic SCI (i.e., >1 year post-injury)
- a traumatic or non-traumatic and non-progressive cause of SCI
- ≥18 years old
- able to stand for 30s unsupported
Key exclusion criteria (4 listed)
- severe spasticity in the legs
- contractures in the lower extremity that prevent achieving a neutral hip and ankle position, or extended knee
- a pressure sore (>grade 2) on the pelvis or trunk where the harness will be applied
- a prior lower extremity fragility fracture.
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 |
|---|---|---|
| Perturbation-based trainingOver-ground practice of stepping and balance tasks in standing with perturbations applied by the trainer (pushes and pulls to the safety harness). One hour in duration with 60 perturbations targeted per hour. | Behavioural | Perturbation-based training |
| Conventional walking trainingOver-ground practice of stepping and balance tasks in standing. One hour in duration. | Behavioural | Conventional walking training |
Primary outcome
Change in reactive stepping ability (Lean and Release Test)
Time frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
Inness EL, Mansfield A, Biasin L, et al. Clinical implementation of a reactive balance control assessment in a sub-acute stroke patient population using a 'lean-and-release' methodology. Gait \& Posture 2015; 41: 529-34.
5 secondary outcomes
Change in the Mini-BESTest score
Time frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
Change in the Activities-specific Balance Confidence Scale score
Time frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
Change in the Community Balance & Mobility Scale
Time frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
Change in spatiotemporal measures of gait
Time frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
Change in the Falls Efficacy Scale - International score
Time frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training
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 24 Mar 2020.
- Derived from this study: PubMed 37037014Heffernan MG, Lee JW, Chan K, Unger J, Marzolini S, Welsh TN, Masani K, Musselman KE. Spatial characteristics of reactive stepping among people living with chronic incomplete spinal cord injury. J Spinal Cord Med. 2023 Sep;46(5):769-777. doi: 10.1080/10790268.2023.2175575. Epub 2023 Apr 10.
- Derived from this study: PubMed 33603710Unger J, Chan K, Lee JW, Craven BC, Mansfield A, Alavinia M, Masani K, Musselman KE. The Effect of Perturbation-Based Balance Training and Conventional Intensive Balance Training on Reactive Stepping Ability in Individuals With Incomplete Spinal Cord Injury or Disease: A Randomized Clinical Trial. Front Neurol. 2021 Feb 2;12:620367. doi: 10.3389/fneur.2021.620367. eCollection 2021.
- Derived from this study: PubMed 33263499Unger J, Oates AR, Lanovaz J, Chan K, Lee JW, Theventhiran P, Masani K, Musselman KE. The measurement properties of the Lean-and-Release test in people with incomplete spinal cord injury or disease. J Spinal Cord Med. 2022 May;45(3):426-435. doi: 10.1080/10790268.2020.1847562. Epub 2020 Dec 2.
- Individual participant dataSharing planned: No
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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 Perturbation-based training and Conventional walking training in people with Spinal Cord Injuries, run by University Health Network, Toronto 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 8 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 24 Mar 2020. 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?
Change in reactive stepping ability (Lean and Release Test) (time frame: Baseline, after 4 weeks of training, after 8 weeks of training, 3 months after the end of training, 6 months after the end of training). 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 NCT02960178, which also lists 3 linked publications.
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 24 Mar 2020.