Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury

NCT04340063 | Completed Results FDA Device

• 2 other identifiers: B3371-RI01RX003371
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Incomplete Spinal Cord Injury

Keywords

gait; locomotion; walking; balance; spinal cord injury; rehabilitation robotics

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  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

  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

  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)

  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)

  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)

Study Arms (2)

Treadmill group

ACTIVE COMPARATOR

Participants randomized to the Treadmill group will complete high intensity gait training on a treadmill.

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.

Device: Gait training performed in a Movement Amplification Environment

Interventions

Gait training performed on a treadmill DEVICE

Participants randomized to the Control group will complete high intensity gait training on a treadmill.

Also known as: Treadmill Group

Treadmill group

Gait training performed in a Movement Amplification Environment DEVICE

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

Also known as: Movement Amplification Group

Movement Amplification group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead
• Northwestern University: collaborator

Study Sites (1)

Edward Hines Jr. VA Hospital, Hines, IL

Hines, Illinois, 60141-3030, United States

Location

Related Publications (1)

• 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.

  PMID: 39097695 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Results Point of Contact

• Title: Dr. Keith Gordon
• Organization: Edward Hines Jr. VA

keith.gordon2@va.gov

(312) 503-3339

Study Officials

• Keith E Gordon, PhD

  Edward Hines Jr. VA Hospital, Hines, IL

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Study personnel performing the clinical assessments will be blinded to the intervention.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 6, 2020
• First Posted: April 9, 2020
• Study Start: October 15, 2020
• Primary Completion: March 31, 2024
• Study Completion: March 31, 2024
• Last Updated: May 29, 2025
• Results First Posted: May 29, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be available following the completion and publication of study results.
• Access Criteria: Data will be publicly available.

Locations

US (1)