Clinical trial NCT05695911: Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
Official title: Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Amputation
Transfemoral Amputation
Osseointegration
Keywords: amputation
osseointegration
rehabilitation
biofeedback
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2023-01-25
Enrollment: 25
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomized by ratio of 1:2 in the CTL to EXP group.
Primary purpose: TREATMENT

Brief summary: This randomized controlled trial (n=25 enrolled, n=15 expected to complete) will 1) determine the feasibility of a 40-week limb-load biofeedback training intervention, 2) determine if there is an intervention signal of efficacy, and 3) identify functional movement priorities for people with transfemoral osseointegrated (OI) prostheses. A limb-load biofeedback training group (EXP (n=10)) will be compared to a standard of care attention-control group without limb-load biofeedback training (CTL (n=5)). Outcomes will be assessed at standard of care pre-habilitation end (Week 5), standard of care rehabilitation end (Week 24), and one year after OI Stage 2 surgery (Week 64).

Detailed description: This will be a randomized controlled trial with a limb-load biofeedback training (EXP) group and an attention control standard-of-care (CTL) group (2:1 allocation ratio). Outcomes will be assessed prior to surgery (Week 5), start of the limb-load biofeedback training (Week 24), and one year after surgery (Week 64). This Phase I clinical trial will be among the first randomized controlled rehabilitation trials for people with transfemoral OI prostheses. There is an immediate need to better understand the physical health benefits and factors that contribute to poor outcomes for this population. A critical step in developing rehabilitation guidelines is to identify optimal methods for people to regain active lifestyles, best use their prostheses, and avoid secondary comorbidities. This novel limb-load biofeedback training program will provide the empirical evidence necessary to inform post-OI rehabilitation regimens designed to optimize outcomes. Importantly, data from this trial will also guide intervention refinement as the investigators move toward a Phase II trial.

Eligibility criteria: Inclusion Criteria:

* Transfemoral unilateral amputation due to traumatic, congenital or cancer related causes
* ≥ 18 years old
* History of severe socket-related skin or residual limb problems
* Schedule for OI prosthesis implantation surgery

Exclusion Criteria:

* Vascular amputation etiology
* Substance abuse
* Unstable heart condition
* Acute systemic infection
* Cognitive impairment (Montreal Cognitive Assessment \[MoCA\] score \<24)
* Active cancer treatment

Primary outcomes:
measure: Intervention Feasibility
timeFrame: Week 64
measure: Intervention Participant Acceptability
timeFrame: Week 64
measure: Intervention Fidelity
timeFrame: Week 64
measure: Change in Cumulative Loading
timeFrame: Week 5, Week 64
measure: Change in Multi-Domain Biomechanics during Tasks of Increasing Biomechanical Demand
timeFrame: Week 5, Week 64
Secondary outcomes:
measure: Change in World Health Organization-Disability Assessment Schedule 2.0
timeFrame: Week 5, Week 24 and Week 64
measure: Change in Activities Specific Balance Confidence Scale
timeFrame: Week 5, Week 24 and Week 64
measure: Change in Prosthetic Limb Users Survey of Mobility
timeFrame: Week 5, Week 24 and Week 64
measure: Change in Patient Specific Function Scale
timeFrame: Week 5, Week 24 and Week 64
measure: Change in Self Selected Gait Speed
timeFrame: Week 5 and Week 64
measure: Change in 30 Second Sit - Stand Test
timeFrame: Week 5, Week 64
measure: Change in Colorado Osseointegrated Limb Donning and Timed Up and Go Test
timeFrame: Week 5, Week 64
Other outcomes:
Locations:
city: Aurora
country: United States
facility: CU Physical Therapy
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: Cory Christiansen, PT PHD
role: PRINCIPAL_INVESTIGATOR
References: