N/A
N=20
Upper Limb Loss Perturbation Response
Amputation
Bottom Line
View on ClinicalTrials.gov: NCT04274218 ↗Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Nov 2024
Primary outcome: Primary: Whole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression — 0.025; 0.031; 0.027; 0.028 Unitless (normalized)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Perturbation (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Jun 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Whole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression |
0.025; 0.031; 0.027; 0.028 | — |
| SECONDARY Shoulder Angle Flexion-extension Range |
36; 34; 5; 31 | — |
| SECONDARY Trunk Flexion Angle |
9.9; 10.1; 10.1; 10.2 | — |
| SECONDARY Trunk Flexion Velocity |
35.2; 34.5; 37.2; 32.9 | — |
Summary
Recent investigations have suggested that persons with upper limb loss experience a high prevalence of falls with a quarter of reported falls resulting from a trip. Moreover, studies indicate that missing part of an arm may negatively impact balance and that use of a prosthesis exacerbates this problem. While the investigators are beginning to understand the effects of upper limb loss on balance, the understanding of how Veterans with upper limb loss respond to walking disturbances is incomplete. Therefore, the aims of this study are to observe the effects of upper limb loss and wearing a prosthesis on the preparation and recovery of Veterans who trip during walking. The investigators plan to use unique treadmill technology to deliver controlled, yet unexpected, perturbations to Veterans with upper limb loss and non-amputee controls, and assess walking stability through body dynamics. Results from this study will help us understand why Veterans with upper limb loss fall as a critical first step to addressing this problem through balance-targeted interventions that are integrated into patient care.
Eligibility Criteria
Inclusion Criteria
Participant inclusion criteria for all participants include:
- age between 18 and 65 years
- normal or corrected vision
- able to walk unassisted for 20 minutes without undue fatigue or health risks
Additional inclusion criteria for participants with ULL include:
- unilateral ULL at the transradial level
- most recent major upper limb amputation occurred at least one year prior to study
- residuum and amputated side in good condition (no scars, infections, pain, etc.)
- habitual experience using an upper limb prosthesis for at least one year
- a self-reported comfortable prosthetic suspension
Exclusion Criteria
Exclusion criteria for all participants include:
- self-reported additional neurological, vascular, or musculoskeletal pathologies (other than ULL when applicable) that may affect proprioception/balance
- self-reported medication that may affect proprioception/balance, e.g.:
- drugs that are ototoxic, such as certain Aminoglycosides and pain killers
- cognitive deficits that preclude understanding of the study instructions
- presence of osteoporosis
- presence of pacemakers or stents that may be irritated by the chest harness
Data sourced from ClinicalTrials.gov (NCT04274218). 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.