Incomplete Spinal Cord InjuryAGILE SCINCT04340063
Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury
A study testing Gait training performed on a treadmill and Gait training performed in a Movement Amplification Environment in people with Incomplete Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Spinal cord injury (SCI) affects ~42,000 Veterans. The VA provides the single largest network of SCI care in the nation. The lifetime financial burden of SCI can exceed $3 million. A major cost of SCI is impaired mobility. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Incomplete Spinal Cord Injury
- What is being tested?
- Gait training performed on a treadmill and Gait training performed in a Movement Amplification Environment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2020to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Medically stable with medical clearance from a physician to participate
- Neurologic level of the SCI between C1-T10 with American Spinal Injury Association (ASIA) Impairment Scale (AIS) C or D
- > 6 months since initial injury
- Passive range of motion of the legs within functional limits and not restricting the ability to engage in locomotor training
- Able to ambulatory 10m with no physical assistance, use of assistive devices (e.g. single cane, rolling walker), and/or braces that do not cross the knee joint (e.g. ankle foot orthosis) are permitted
- Able to provide transportation to and from the testing location.
Who cannot join
- Excessive spasticity in the lower limbs as measured by a score of > 3 on the Modified Ashworth Scale
- Inability to tolerate 30 minutes of standing
- Severe cardiovascular and pulmonary disease
- History of recurrent fractures or known orthopedic problems in the lower extremities (i.e. heterotopic ossification)
- Concomitant central or peripheral neurological injury (i.e. traumatic head injury or peripheral nerve damage in lower limbs)
- Inability to provide informed consent due to cognitive impairments
Show all 10Show fewer
- Presence of unhealed decubiti or other skin compromise
- Enrollment in concurrent physical therapy or research involving locomotor training
- Use of braces/orthotics crossing the knee joint
- Known pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
Edward Hines Jr. VA Hospital, Hines, IL
Hines, Illinois, 60141-3030
About this study
Official title: Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI) Trial
Spinal cord injury (SCI) affects ~42,000 Veterans. The VA provides the single largest network of SCI care in the nation. The lifetime financial burden of SCI can exceed $3 million. A major cost of SCI is impaired mobility. Limited mobility contributes to decreased ability to work, increased care requirements, secondary injury, depression, bone mineral density loss, diabetes, and decreased cardiovascular health. Among ambulatory individuals with iSCI, residual balance deficits are common and are strongly correlated with both functional walking ability and participation in walking activities. The development of effective rehabilitation tools to improve dynamic balance would substantially improve quality of life for Veterans living with iSCI. Improving mobility through interventions that enhance dynamic balance would positively impact health, independence, and the ability to integrate into social, intellectual, and occupational environments.
Read the detailed description
Background:
Among ambulatory individuals with incomplete spinal cord injury (iSCI), residual balance deficits are common and are a primary factor limiting participation in walking activities. There is broad recognition that effective evidence-based interventions are needed to enhance dynamic balance following iSCI. However, improving dynamic balance after iSCI has proven to be very challenging. Experimental interventions that amplify self-generated movements (e.g. error augmentation) may accelerate motor learning by intensifying sensory motor feedback and facilitating exploration of alternative motor control strategies. These features may be beneficial for retraining dynamic balance after iSCI. The investigators have developed a cable-driven robot to create a movement amplification environment during treadmill walking by applying a continuous viscous force field to the pelvis that is proportional in magnitude to a participant's real-time range of motion (ROM) velocity. The purpose is to investigate if locomotor training performed in a movement amplification environment can effectively improve dynamic balance and increase participation in walking activities of individuals with iSCI.
Specific Aims:
Aim 1: To evaluate if locomotor training performed in a movement amplification environment is effective for improving dynamic balance of individuals with iSCI. The investigators' pilot data found that following locomotor training performed in a movement amplification environment three individuals with iSCI each improved dynamic balance by more than 30%. These improvements were accompanied by faster over ground walking speeds and improved reactive balance. Thus, the investigators hypothesize that improvements in dynamic balance during walking will be greater when locomotor training is performed in a movement amplification environment when compared to locomotor training performed in a traditional treadmill environment.
Aim 2: To evaluate the impact of locomotor training performed in either a movement amplification environment or in a traditional treadmill environment on participation in walking activities. Based on evidence identifying a strong relationship between balance and steps per day in ambulatory individuals with iSCI, the investigators hypothesize that training in the movement amplification environment will positively impact dynamic balance, and in turn increase participating in walking activities.
Approach:
The investigators will conduct a two-arm parallel-assignment intervention and will enroll 36 ambulatory participants with chronic motor incomplete spinal cord injury. Participants will be randomized into either a Control group receiving locomotor training or an Experimental group receiving locomotor training performed in a movement amplification environment. All participants will receive 20 training sessions. The investigators will assess changes in dynamic balance using measures that span the International Classification of Functioning, Disability and Health (ICF) framework including; 1) clinical outcome measures of gait, balance, and quality of life, 2) biomechanical assessments of the capacity to control center of mass (COM) motion during walking, and 3) data collected from activity monitors to quantify changes in participation in walking activities as evaluated by number of steps taken per day.
Impact:
Training dynamic balance of individuals with iSCI by amplifying their own self-generated center of mass motion during walking is a radical departure from current practice and may create effective new clinical strategies for addressing balance impairments of individuals with iSCI. Successful outcomes from the proposed trial would motivate development of clinically-feasible tools to first replicate and then to evaluate the movement amplification environment within the VA's clinical care settings. Knowledge gained from this study will expand the understanding of how individuals with iSCI learn dynamic balance and how targeted dynamic balance training impacts participation in walking activities.
- Conditions
- Incomplete Spinal Cord Injury
- Being tested
- Gait training performed on a treadmill, Gait training performed in a Movement Amplification Environment
- Keywords
- gait, locomotion, walking, balance, spinal cord injury, rehabilitation robotics
- 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.
Gait training performed on a treadmillDevice
Also called Treadmill Group
Participants randomized to the Control group will complete high intensity gait training on a treadmill.
Gait training performed in a Movement Amplification EnvironmentDevice
Also called Movement Amplification Group
The Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking
| Study group | Role | What they receive |
|---|---|---|
| Treadmill group | Active comparator | Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill. Receives: Device: Gait training performed on a treadmill |
| Movement Amplification group | Experimental | The locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment. Receives: Device: Gait training performed in a Movement Amplification Environment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Gait Assessment (FGA)
The FGA is a ten-item test that evaluates dynamic balance and postural stability during gait. Each item on the test is scored from 0 (severe impairment) to 3 (normal ambulation). Total score of this test is 30, with higher score indicating better walking balance. Lowest possible score is 0.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Lateral Center of Mass Excursion
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average lateral center of mass excursion occurring each stride during treadmill walking.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Daily Stepping
The investigators will assess the amount of daily stepping in the home and community during three 1-week periods. Daily stepping will be measured and recorded using an activity monitor. HIgher number of daily stepping indicates greater physical activity levels or greater walking in the community setting.
Measured: Pre-training assessment (Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Secondary outcomes (17)
10 Meter Walk Test (10MWT)_Fast Speed
The 10MWT is a simple measurement of an individuals average walking speed.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
10 Meter Walk Test (10MWT)_Preferred Speed
The 10MWT is a simple measurement of an individuals average walking speed.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Activities Specific Balance Confidence (ABC) Scale
The ABC scale is a 16-item self-report measurement of an individual's confidence while performing numerous postural and ambulatory activities. Each item is rated on a scale of 0 (no confidence) to 100 (complete confidence). Overall score is calculated by adding item scores and then dividing by the total number of items. Total score is 100. Higher score indicates greater balance confidence i.e. ability to perform tasks with less or no fear of falling. Lowest possible score is 0.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Balance Evaluations Systems Test (BESTest)
The BESTest is used to assess balance impairments across six different domains of postural control. We will use only the reactive balance item from the BESTest to assess changes in the capacity to react to fore-aft, and lateral perturbations. Each item will be scored on a range from 0 (severe impairment) to 3 (no impairment). Highest score is 6 and lowest possible score is 0. Higher score indicates better ability to restore balance and better reactive stepping response during standing perturbation.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Berg Balance Scale (BBS)
The BBS is a 14-item measure that assesses static balance. Each item is scored on a range of 0 to 4. A total score is determined by summing scores on the all the individual items. Total score is 56. Higher score indicates better static balance. Lowest possible score is 0.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
The ICIQ-UI SF is a 4-item self-report of urinary incontinence to document changes in bladder function. Scores range from 0-21, with greater values indicating increased severity.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Lower Extremity Motor Score
The lower extremity motor score assess strength of five muscle groups representing neurological levels L2 to S1. Muscle function is grade on a range from 0 (total paralysis) to 5 (active movement, full range of motion (ROM) against gravity and sufficient resistance to be considered normal. Total score is 50. Higher score indicates better or more complete motor function in the lower extremities. Lowest possible score is 0.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Timed Up and Go (TUG)
The Timed Up and Go Test (TUG) assesses mobility, balance, walking ability, and fall risk. The participant sits in a chair with his/her back against the chair back. On the command "go," the patient rises from the chair, walks 3 meters at a comfortable and safe pace, turns, walks back to the chair and sits down. Time to complete the task is reported. Participant must use the same assistive device each time he/she is tested to be able to compare scores.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Walking Index for Spinal Cord Injury II (WISCI II)
The WISCI II evaluates the amount of physical assistance needed for gait after spinal cord injury. The index ranges from 0 (client is unable to stand and/or participate in assisted walking) to 20 (ambulates with no devices, no braces and no physical assistance, 10 meters). Highest score is 20 and lowest possible score is 0. Higher score indicates better ability to ambulate at least a distance of 10 meters without assistance from assistive device and/or from other person.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The physical domain focuses on patients perception about his physical health including items related to mobility, daily activities, functional capacity, energy, pain, and sleep. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The psychological domain focuses on patients perception about their psychological well-being, encompassing aspects like self-image, negative and positive feelings, self-esteem, and mental status. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The social relations domain focuses on patients perception about their social connections, support, and sexual life, contributing to their overall quality of life. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment
The WHOQOL-BREF is a 26 item self-report quality of life assessment focusing on 4 different domains: physical, psychological, social relations and environment. The environment domain focuses on patients perception about their surroundings, including factors like financial resources, safety, access to services, home environment, and the physical environment. social connections, support, and sexual life, contributing to their overall quality of life. Scores range from 0-100 with 100 indicating higher quality of life. Lowest possible score is 0.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Minimum Lateral Margin of Stability
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average minimum lateral margin of stability (distance between a velocity weighted whole body center of mass position and the edge of the base of support) occurring each step during treadmill walking.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Peak Lateral Center of Mass Speed
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average peak lateral center of mass speed occurring each stride during treadmill walking.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Step Width
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's preferred step width (lateral distance between calcaneal markers) during treadmill walking.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Step Length
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's preferred step length (anterior - posterior distance between calcaneal markers) during treadmill walking.
Measured: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start15 Oct 2020
- Primary completion31 Mar 2024
- Study completion31 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incomplete Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe 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
- Model description
- The investigators will conduct a two-arm parallel assignment intervention. Participants will be randomized into a high intensity locomotor training intervention that will be conducted in either a normal treadmill environment or in a movement amplification environment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- Northwestern University
- Responsible party
- Sponsor
- Investigators
- Keith E Gordon, PhD, Principal investigator, Edward Hines Jr. VA Hospital, Hines, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340063
- Sponsor's protocol ID
- B3371-R
- Other IDs
- I01RX003371
- Acronym
- AGILE SCI
- Status last verified
- May 2025
- First submitted
- 6 Apr 2020
- Last updated
- 29 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The investigators will create and share de-identified, anonymized data sets. Data sets will be open file formats that include documentation of the material. The investigators will link data sets to associated study publications. Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available. These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy. The final data sets will be sufficient for anyone to perform analogous or supplemental analyses that would permit validation of the analysis and results. The sharing of data will enable others to evaluate the data and to validate and interpret the data independently.
Publications
Gordon KE, Dusane S, Kahn JH, Shafer A, Brazg G, Henderson H, Kim KA. Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI) trial: study protocol for an assessor blinded randomized controlled trial. BMC Neurol. 2024 Aug 3;24(1):271. doi: 10.1186/s12883-024-03757-2.
PubMed 39097695
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI) Trial
- ClinicalTrials.gov ID
- NCT04340063
- Acronym / sponsor ID
- AGILE SCI / B3371-R
- Conditions
- Incomplete Spinal Cord Injury
- Keywords
- gait, locomotion, walking, balance, spinal cord injury, rehabilitation robotics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- Northwestern University
- Study start
- 15 Oct 2020 (actual)
- Primary completion
- 31 Mar 2024 (actual)
- Study completion
- 31 Mar 2024 (actual)
- First posted
- 9 Apr 2020 (actual)
- Results
- Posted 29 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Spinal cord injury (SCI) affects ~42,000 Veterans. The VA provides the single largest network of SCI care in the nation. The lifetime financial burden of SCI can exceed $3 million. A major cost of SCI is impaired mobility. Limited mobility contributes to decreased ability to work, increased care requirements, secondary injury, depression, bone mineral density loss, diabetes, and decreased cardiovascular health. Among ambulatory individuals with iSCI, residual balance deficits are common and are strongly correlated with both functional walking ability and participation in walking activities. The development of effective rehabilitation tools to improve dynamic balance would substantially improve quality of life for Veterans living with iSCI. Improving mobility through interventions that enhance dynamic balance would positively impact health, independence, and the ability to integrate into social, intellectual, and occupational environments.
Detailed description
Background:
Among ambulatory individuals with incomplete spinal cord injury (iSCI), residual balance deficits are common and are a primary factor limiting participation in walking activities. There is broad recognition that effective evidence-based interventions are needed to enhance dynamic balance following iSCI. However, improving dynamic balance after iSCI has proven to be very challenging. Experimental interventions that amplify self-generated movements (e.g. error augmentation) may accelerate motor learning by intensifying sensory motor feedback and facilitating exploration of alternative motor control strategies. These features may be beneficial for retraining dynamic balance after iSCI. The investigators have developed a cable-driven robot to create a movement amplification environment during treadmill walking by applying a continuous viscous force field to the pelvis that is proportional in magnitude to a participant's real-time range of motion (ROM) velocity. The purpose is to investigate if locomotor training performed in a movement amplification environment can effectively improve dynamic balance and increase participation in walking activities of individuals with iSCI.
Specific Aims:
Aim 1: To evaluate if locomotor training performed in a movement amplification environment is effective for improving dynamic balance of individuals with iSCI. The investigators' pilot data found that following locomotor training performed in a movement amplification environment three individuals with iSCI each improved dynamic balance by more than 30%. These improvements were accompanied by faster over ground walking speeds and improved reactive balance. Thus, the investigators hypothesize that improvements in dynamic balance during walking will be greater when locomotor training is performed in a movement amplification environment when compared to locomotor training performed in a traditional treadmill environment.
Aim 2: To evaluate the impact of locomotor training performed in either a movement amplification environment or in a traditional treadmill environment on participation in walking activities. Based on evidence identifying a strong relationship between balance and steps per day in ambulatory individuals with iSCI, the investigators hypothesize that training in the movement amplification environment will positively impact dynamic balance, and in turn increase participating in walking activities.
Approach:
The investigators will conduct a two-arm parallel-assignment intervention and will enroll 36 ambulatory participants with chronic motor incomplete spinal cord injury. Participants will be randomized into either a Control group receiving locomotor training or an Experimental group receiving locomotor training performed in a movement amplification environment. All participants will receive 20 training sessions. The investigators will assess changes in dynamic balance using measures that span the International Classification of Functioning, Disability and Health (ICF) framework including; 1) clinical outcome measures of gait, balance, and quality of life, 2) biomechanical assessments of the capacity to control center of mass (COM) motion during walking, and 3) data collected from activity monitors to quantify changes in participation in walking activities as evaluated by number of steps taken per day.
Impact:
Training dynamic balance of individuals with iSCI by amplifying their own self-generated center of mass motion during walking is a radical departure from current practice and may create effective new clinical strategies for addressing balance impairments of individuals with iSCI. Successful outcomes from the proposed trial would motivate development of clinically-feasible tools to first replicate and then to evaluate the movement amplification environment within the VA's clinical care settings. Knowledge gained from this study will expand the understanding of how individuals with iSCI learn dynamic balance and how targeted dynamic balance training impacts participation in walking activities.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The investigators will conduct a two-arm parallel assignment intervention. Participants will be randomized into a high intensity locomotor training intervention that will be conducted in either a normal treadmill environment or in a movement amplification environment.
| Arm | Type | Receives |
|---|---|---|
| Treadmill group | Active comparator | Device: Gait training performed on a treadmillParticipants randomized to the Treadmill group will complete high intensity gait training on a treadmill. |
| Movement Amplification group | Experimental | Device: Gait training performed in a Movement Amplification EnvironmentThe locomotor training protocol described for the Treadmill group will be used for the Movement Amplification group with one exception. The Movement Amplification group will perform all gait training within the movement amplification environment. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Medically stable with medical clearance from a physician to participate
- Neurologic level of the SCI between C1-T10 with American Spinal Injury Association (ASIA) Impairment Scale (AIS) C or D
- > 6 months since initial injury
- Passive range of motion of the legs within functional limits and not restricting the ability to engage in locomotor training
- Able to ambulatory 10m with no physical assistance, use of assistive devices (e.g. single cane, rolling walker), and/or braces that do not cross the knee joint (e.g. ankle foot orthosis) are permitted
Key exclusion criteria (10 listed)
- Excessive spasticity in the lower limbs as measured by a score of > 3 on the Modified Ashworth Scale
- Inability to tolerate 30 minutes of standing
- Severe cardiovascular and pulmonary disease
- History of recurrent fractures or known orthopedic problems in the lower extremities (i.e. heterotopic ossification)
- Concomitant central or peripheral neurological injury (i.e. traumatic head injury or peripheral nerve damage in lower limbs)
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 |
|---|---|---|
| Gait training performed on a treadmillAlso: Treadmill GroupParticipants randomized to the Control group will complete high intensity gait training on a treadmill. | Device | Treadmill group |
| Gait training performed in a Movement Amplification EnvironmentAlso: Movement Amplification GroupThe Experimental group will perform all gait training within the movement amplification environment. To create the movement amplification environment, the investigators have constructed a cable-driven robot, the Agility Trainer. The Agility Trainer applies small forces to the pelvis that increase the difficulty to maintain forward walking | Device | Movement Amplification group |
Primary outcome
Functional Gait Assessment (FGA)
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
The FGA is a ten-item test that evaluates dynamic balance and postural stability during gait. Each item on the test is scored from 0 (severe impairment) to 3 (normal ambulation). Total score of this test is 30, with higher score indicating better walking balance. Lowest possible score is 0.
Lateral Center of Mass Excursion
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
The investigators will perform biomechanical laboratory assessments to make quantitative measures of changes in dynamic balance during walking. The investigators will record 3D coordinates of reflective markers placed on anatomical landmarks. These markers will be used to quantify changes in an individual's average lateral center of mass excursion occurring each stride during treadmill walking.
Daily Stepping
Time frame: Pre-training assessment (Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
The investigators will assess the amount of daily stepping in the home and community during three 1-week periods. Daily stepping will be measured and recorded using an activity monitor. HIgher number of daily stepping indicates greater physical activity levels or greater walking in the community setting.
17 secondary outcomes
10 Meter Walk Test (10MWT)_Fast Speed
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
10 Meter Walk Test (10MWT)_Preferred Speed
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Activities Specific Balance Confidence (ABC) Scale
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Balance Evaluations Systems Test (BESTest)
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Berg Balance Scale (BBS)
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF)
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Lower Extremity Motor Score
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Timed Up and Go (TUG)
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Walking Index for Spinal Cord Injury II (WISCI II)
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Minimum Lateral Margin of Stability
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Peak Lateral Center of Mass Speed
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Step Width
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Step Length
Time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39097695Gordon KE, Dusane S, Kahn JH, Shafer A, Brazg G, Henderson H, Kim KA. Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury (AGILE SCI) trial: study protocol for an assessor blinded randomized controlled trial. BMC Neurol. 2024 Aug 3;24(1):271. doi: 10.1186/s12883-024-03757-2.
- Individual participant dataSharing planned: Yes. The investigators will create and share de-identified, anonymized data sets. Data sets will be open file formats that include documentation of the material. The investigators will link data sets to associated study publications. Final data sets will be made available as per Hines VA Hospital local policy for long term storage and access until enterprise-level resources become available. These data will be available upon request by researchers and scientists in accordance with federal guidelines and Hines local policy. The final data sets will be sufficient for anyone to perform analogous or supplemental analyses that would permit validation of the analysis and results. The sharing of data will enable others to evaluate the data and to validate and interpret the data independently.
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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.
Keith E Gordon, PhD principal investigator
Edward Hines Jr. VA Hospital, Hines, IL
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gait training performed on a treadmill and Gait training performed in a Movement Amplification Environment in people with Incomplete Spinal Cord Injury, run by VA Office of Research and Development 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 10 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 29 May 2025. 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?
Yes. Results are posted in the registry (first posted 29 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Functional Gait Assessment (FGA) (time frame: Pre-training assessment (Baseline), Mid-training assessment (after 10 sessions, ~5 weeks from Baseline), Post-training assessment (after 20 sessions, ~10 weeks from Baseline), Follow-up assessment (3 month from Post, ~6 months from Baseline)). The study lists 3 primary outcomes in all. 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 NCT04340063, 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 29 May 2025.