N/A
N=36
Amplify Gait to Improve Locomotor Engagement in Spinal Cord Injury
Incomplete Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT04340063 ↗Enrolled (actual)
36
Serious AEs
16.7%
Results posted
May 2025
Primary outcome: Primary: Functional Gait Assessment (FGA) — 15.22; 14.22; 19.38; 18.13 score on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Gait training performed on a treadmill (Device); Gait training performed in a Movement Amplification Environment (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Functional Gait Assessment (FGA) |
15.22; 14.22; 19.38; 18.13; 20.29; 19.88 | <0.001 sig |
| PRIMARY Lateral Center of Mass Excursion |
10.16; 9.82; 8.51; 7.42; 8.43; 7.19 | 0.8 |
| PRIMARY Daily Stepping |
5,680; 3,264; 5,480; 4,284; 6,041; 3,530 | 0.9 |
| SECONDARY 10 Meter Walk Test (10MWT)_Fast Speed |
0.86; 0.87; 1.14; 1.01; 1.15; 1.08 | — |
| SECONDARY 10 Meter Walk Test (10MWT)_Preferred Speed |
0.65; 0.65; 0.83; 0.72; 0.83; 0.79 | — |
| SECONDARY Activities Specific Balance Confidence (ABC) Scale |
62.62; 65.39; 71.97; 75; 73.50; 74.06 | — |
| SECONDARY Balance Evaluations Systems Test (BESTest) |
2.64; 1.88; 2.92; 2.13; 2.79; 2.40 | — |
| SECONDARY Berg Balance Scale (BBS) |
41.78; 41.67; 45.46; 46.63; 46.79; 48.38 | — |
| SECONDARY International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) |
4.43; 4.19; 3.21; 3.63; 4.07; 4.31 | — |
| SECONDARY Lower Extremity Motor Score |
39.33; 40.39; 41.14; 40.88; 41.71; 41.44 | — |
| SECONDARY Timed Up and Go (TUG) |
34.18; 33.92; 21.49; 27.51; 23.59; 25.85 | — |
| SECONDARY Walking Index for Spinal Cord Injury II (WISCI II) |
16.17; 14.89; 17.57; 16.25; 18.00; 16.94 | — |
| SECONDARY The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Physical |
74.29; 62.63; 71.57; 55.69; 73.79; 65.06 | — |
| SECONDARY The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Psychological |
76.00; 66.50; 75.93; 64.19; 78.07; 70.81 | — |
| SECONDARY The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Social Relations |
69.21; 60.56; 66.07; 62.94; 65.46; 57.81 | — |
| SECONDARY The World Health Organization Quality of Life Scale (WHOQOL-BREF)_Environment |
80.50; 79.44; 77.86; 75.63; 80.93; 77.06 | — |
| SECONDARY Minimum Lateral Margin of Stability |
5.84; 4.96; 6.16; 5.0; 6.33; 4.73 | — |
| SECONDARY Peak Lateral Center of Mass Speed |
0.25; 0.22; 0.29; 0.23; 0.29; 0.27 | — |
| SECONDARY Step Width |
0.27; 0.26; 0.26; 0.24; 0.26; 0.25 | — |
| SECONDARY Step Length |
0.27; 0.28; 0.37; 0.41; 0.41; 0.45 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT04340063). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.