AmputationNCT04274218
Upper Limb Loss Perturbation Response
A study testing Perturbation in people with Amputation, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Amputation
- What is being tested?
- Perturbation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Dec 2020to 30 Jun 2022
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Jesse Brown VA Medical Center, Chicago, IL
Chicago, Illinois, 60612
About this study
Official title: Locomotor Response of Persons With Upper Limb Loss to Treadmill Perturbations
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.
Read the detailed description
The primary aim of this pilot study is to characterize the proactive and reactive locomotor response of Veterans with upper limb loss (ULL) to a trip during walking. The investigators' recent VA-funded investigations have suggested that persons with ULL experience a high prevalence of falls and demonstrate postural control mechanisms that may impair stability. Specifically, nearly half of individuals with ULL at or proximal to the wrist level experience at least one fall per year and almost a third will experience two or more falls. Further, use of a prosthesis increases the likelihood of falling by six times, 25% of reported falls resulted from tripping, and nearly a third of individuals who experience a fall suffer a fall-related injury. Falls can have considerable economic burden on the VHA and lead to long-term diminished quality of life. The investigators' biomechanical studies suggest that persons with unilateral ULL display greater postural sway during standing than able-bodied individuals which increases when wearing a prosthesis, and right/left asymmetry in locomotor stability dynamics that may increase the risk of falling toward the impaired limb side and during sound limb side strides. These findings emphasize the need for additional research to better understand the mechanisms Veterans with ULL use to control balance and how wearing a prosthesis affects these strategies. As the investigators' previous research was concerned with steady-state characterization of postural control, the investigators now plan to build on this work by studying the effects of ULL and wearing a prosthesis on locomotor stability when responding to a trip disturbance during walking. In this context, locomotor stability is defined as the ability to recover from a perturbation and return to steady-state gait.
The investigators will address the study aims by analyzing trip-induced proactive and reactive locomotor strategy differences in two study comparisons: 1) Veterans with unilateral transradial level ULL against matched able-bodied controls (with and without one arm bound), and 2) Veterans with unilateral transradial ULL when wearing their customary prosthesis against not wearing their prosthesis. Controlled, yet unexpected, simulated trips will be delivered through the investigators' custom-built treadmill which permits programmable belt velocity disturbances and allows participants to continue walking following recovery. The investigators will characterize the proactive and reactive locomotor stability mechanisms through a set of biomechanical (angular momentum, arm and trunk kinematics) variables. Biomechanical variables will be quantified using an optical motion capture system. The investigators expect that Veterans with ULL will demonstrate altered locomotor stability mechanisms compared to controls, and these differences will exist between wearing and not wearing their customary prosthesis. Results from this study will help us characterize the underlying mechanisms of locomotor stability in Veterans with ULL and identify the factors associated with their increased prevalence of trip-related falls. Such knowledge is a critical first step to addressing this public health problem through stability-targeted rehabilitation interventions aimed at reducing falls, fall-related injuries, and associated VHA costs in this Veteran patient group. The investigators will use the outcomes from this pilot study to guide future VA Merit Award proposals to develop and assess physical training intervention methods and wearable and prosthetic technology to improve stability in Veterans with ULL. The VHA is an ideal venue to pursue this work as one of its main priorities is to elevate the standard-of-care for Veterans with limb loss.
- Conditions
- Amputation
- Being tested
- Perturbation
- Keywords
- Stability, Locomotion, Motor Control, Trip, Falls, Upper Limb Loss, Prosthesis, Arm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerturbationOther
Participants from both cohorts will experience a simulated trip while walking on the treadmill. The trip is induced through a rapid acceleration and deceleration of the treadmill belt speed.
| Study group | Role | What they receive |
|---|---|---|
| Walking perturbation - Free | Experimental | Healthy controls without limb loss and individuals with upper limb loss between the wrist and elbow will receive a treadmill belt disturbance while walking. Able-bodied individuals will walk with both arms free and individuals with amputation will walk with their prosthesis. Receives: Other: Perturbation |
| Walking perturbation - Limited | Experimental | Healthy controls without limb loss and individuals with upper limb loss between the wrist and elbow will receive a treadmill belt disturbance while walking. Able-bodied individuals will walk with one arm bound to their side with straps and individuals with amputation will walk without their prosthesis. Receives: Other: Perturbation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Whole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression
Whole-body angular momentum is the momentum of all limb segments about the Body Center of Mass (BCoM) summed. Whole-body angular momentum is estimated in the sagittal plane, which is the plane of walking progression, and the range of this value is normalized to a person's body mass, height, and walking speed. Whole body angular momentum is minimized by the central nervous system to facilitate postural control. For this study, whole body angular momentum range was averaged across the 12 perturbation trials and then across all participants. To note, the reported whole body angular momentum values are the relative increase from baseline to perturbation recovery that are all measured in the same session. There are no additional sessions as the baseline whole body angular momentum reflects those values before the perturbation trials.
Measured: 1 hour
Secondary outcomes (3)
Shoulder Angle Flexion-extension Range
Range-of-motion for shoulder joint angle flexion-extension of the impaired or non-dominant arm (Deg) during perturbation recovery; Dynamics used for postural control to regulate and reduce whole-body angular momentum during trip response.
Measured: 1 hour
Trunk Flexion Angle
Maximum flexion angle (degrees) of the trunk during perturbation recovery.
Measured: 1 hour
Trunk Flexion Velocity
Maximum trunk flexion velocity (deg/s) during perturbation recovery
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2020
- Study start11 Dec 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
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.
- Other trials for AmputationStudies 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will receive a small treadmill belt disturbance while walking.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Matthew J. Major, PhD, Principal investigator, Jesse Brown VA Medical Center, Chicago, IL
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04274218
- Sponsor's protocol ID
- A3290-P
- Other IDs
- 1I21RX003290-01A1
- Status last verified
- Nov 2024
- First submitted
- 11 Feb 2020
- Last updated
- 14 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Locomotor Response of Persons With Upper Limb Loss to Treadmill Perturbations
- ClinicalTrials.gov ID
- NCT04274218
- Acronym / sponsor ID
- A3290-P
- Conditions
- Amputation
- Keywords
- Stability, Locomotion, Motor Control, Trip, Falls, Upper Limb Loss, Prosthesis, Arm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 11 Dec 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Feb 2020 (actual)
- Results
- Posted 14 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The primary aim of this pilot study is to characterize the proactive and reactive locomotor response of Veterans with upper limb loss (ULL) to a trip during walking. The investigators' recent VA-funded investigations have suggested that persons with ULL experience a high prevalence of falls and demonstrate postural control mechanisms that may impair stability. Specifically, nearly half of individuals with ULL at or proximal to the wrist level experience at least one fall per year and almost a third will experience two or more falls. Further, use of a prosthesis increases the likelihood of falling by six times, 25% of reported falls resulted from tripping, and nearly a third of individuals who experience a fall suffer a fall-related injury. Falls can have considerable economic burden on the VHA and lead to long-term diminished quality of life. The investigators' biomechanical studies suggest that persons with unilateral ULL display greater postural sway during standing than able-bodied individuals which increases when wearing a prosthesis, and right/left asymmetry in locomotor stability dynamics that may increase the risk of falling toward the impaired limb side and during sound limb side strides. These findings emphasize the need for additional research to better understand the mechanisms Veterans with ULL use to control balance and how wearing a prosthesis affects these strategies. As the investigators' previous research was concerned with steady-state characterization of postural control, the investigators now plan to build on this work by studying the effects of ULL and wearing a prosthesis on locomotor stability when responding to a trip disturbance during walking. In this context, locomotor stability is defined as the ability to recover from a perturbation and return to steady-state gait.
The investigators will address the study aims by analyzing trip-induced proactive and reactive locomotor strategy differences in two study comparisons: 1) Veterans with unilateral transradial level ULL against matched able-bodied controls (with and without one arm bound), and 2) Veterans with unilateral transradial ULL when wearing their customary prosthesis against not wearing their prosthesis. Controlled, yet unexpected, simulated trips will be delivered through the investigators' custom-built treadmill which permits programmable belt velocity disturbances and allows participants to continue walking following recovery. The investigators will characterize the proactive and reactive locomotor stability mechanisms through a set of biomechanical (angular momentum, arm and trunk kinematics) variables. Biomechanical variables will be quantified using an optical motion capture system. The investigators expect that Veterans with ULL will demonstrate altered locomotor stability mechanisms compared to controls, and these differences will exist between wearing and not wearing their customary prosthesis. Results from this study will help us characterize the underlying mechanisms of locomotor stability in Veterans with ULL and identify the factors associated with their increased prevalence of trip-related falls. Such knowledge is a critical first step to addressing this public health problem through stability-targeted rehabilitation interventions aimed at reducing falls, fall-related injuries, and associated VHA costs in this Veteran patient group. The investigators will use the outcomes from this pilot study to guide future VA Merit Award proposals to develop and assess physical training intervention methods and wearable and prosthetic technology to improve stability in Veterans with ULL. The VHA is an ideal venue to pursue this work as one of its main priorities is to elevate the standard-of-care for Veterans with limb loss.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will receive a small treadmill belt disturbance while walking.
| Arm | Type | Receives |
|---|---|---|
| Walking perturbation - Free | Experimental | Other: PerturbationHealthy controls without limb loss and individuals with upper limb loss between the wrist and elbow will receive a treadmill belt disturbance while walking. Able-bodied individuals will walk with both arms free and individuals with amputation will walk with their prosthesis. |
| Walking perturbation - Limited | Experimental | Other: PerturbationHealthy controls without limb loss and individuals with upper limb loss between the wrist and elbow will receive a treadmill belt disturbance while walking. Able-bodied individuals will walk with one arm bound to their side with straps and individuals with amputation will walk without their prosthesis. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- age between 18 and 65 years
- normal or corrected vision
- able to walk unassisted for 20 minutes without undue fatigue or health risks
- unilateral ULL at the transradial level
- most recent major upper limb amputation occurred at least one year prior to study
Key exclusion criteria (6 listed)
- 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.:
- 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
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 |
|---|---|---|
| PerturbationParticipants from both cohorts will experience a simulated trip while walking on the treadmill. The trip is induced through a rapid acceleration and deceleration of the treadmill belt speed. | Other | Walking perturbation - Free, Walking perturbation - Limited |
Primary outcome
Whole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression
Time frame: 1 hour
Whole-body angular momentum is the momentum of all limb segments about the Body Center of Mass (BCoM) summed. Whole-body angular momentum is estimated in the sagittal plane, which is the plane of walking progression, and the range of this value is normalized to a person's body mass, height, and walking speed. Whole body angular momentum is minimized by the central nervous system to facilitate postural control. For this study, whole body angular momentum range was averaged across the 12 perturbation trials and then across all participants. To note, the reported whole body angular momentum values are the relative increase from baseline to perturbation recovery that are all measured in the same session. There are no additional sessions as the baseline whole body angular momentum reflects those values before the perturbation trials.
3 secondary outcomes
Shoulder Angle Flexion-extension Range
Time frame: 1 hour
Trunk Flexion Angle
Time frame: 1 hour
Trunk Flexion Velocity
Time frame: 1 hour
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Matthew J. Major, PhD principal investigator
Jesse Brown VA Medical Center, Chicago, 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 Perturbation in people with Amputation, 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 10 inclusion and 6 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 14 Nov 2024. 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 14 Nov 2024). 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?
Whole-body Angular Momentum in Sagittal-plane; Momentum of the Body in the Sagittal Plane of Walking Progression (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Nov 2024.