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Limb Load Biofeedback Training for Osseointegration (TOPLOAD Trial)

N/A
Recruiting
Led By Cory Christiansen, PT PHD
Research Sponsored by University of Colorado, Denver
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 5, week 24 and week 64
Awards & highlights

TOPLOAD Trial Summary

This trial will test if a limb-load biofeedback training intervention can help people with transfemoral OI prostheses. Outcomes will be evaluated at 5, 24, & 64 weeks.

Who is the study for?
This trial is for adults over 18 with a single below-knee amputation from trauma, birth defects, or cancer. They should have had issues with prosthetic sockets and be scheduled for osseointegration surgery. It's not open to those with substance abuse, unstable heart conditions, vascular-related amputations, infections, cognitive impairments (MoCA score <24), or active cancer treatment.Check my eligibility
What is being tested?
The study tests a limb-load biofeedback training program against standard care without this feature in people getting transfemoral osseointegrated prostheses. The goal is to see if the training helps balance the load on limbs during rehabilitation over a period of up to one year post-surgery.See study design
What are the potential side effects?
Since this trial focuses on physical therapy techniques rather than medication or invasive procedures, side effects may include muscle soreness or fatigue due to exercise but are generally expected to be minimal.

TOPLOAD Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 5, week 24 and week 64
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 5, week 24 and week 64 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Cumulative Loading
Change in Multi-Domain Biomechanics during Tasks of Increasing Biomechanical Demand
Intervention Feasibility
+2 more
Secondary outcome measures
Change in 30 Second Sit - Stand Test
Change in Activities Specific Balance Confidence Scale
Change in Colorado Osseointegrated Limb Donning and Timed Up and Go Test
+4 more

TOPLOAD Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Limb Load Biofeedback Training InterventionExperimental Treatment1 Intervention
The limb-load biofeedback training focuses on altering habitual movement patterns to promote proper prosthetic limb loading with an emphasis on between-limb loading symmetry. Participants randomized to the EXP group will receive 12 biofeedback training sessions (1 in-person, 11 telehealth) tapered over 40 weeks.
Group II: Attention Control InterventionPlacebo Group1 Intervention
The CTL group intervention will include the same standard of care rehabilitation sessions as the EXP group and receive the same computer tablets for telehealth sessions as the EXP group. The CTL group will also have attention control educational sessions at the same frequency, timing, and duration as the EXP group limb-load biofeedback sessions (12 total sessions) with the first session being an in-person session at the Week 24. There will be no biofeedback training intervention in the CTL group. As such, there will be no behavioral intervention or wearable sensors provided to the CTL group. The 12 sessions of EXP group limb-load biofeedback training sessions will be replaced by education-only session in the CTL group.

Find a Location

Who is running the clinical trial?

University of Colorado, DenverLead Sponsor
1,755 Previous Clinical Trials
2,166,394 Total Patients Enrolled
United States Department of DefenseFED
872 Previous Clinical Trials
329,865 Total Patients Enrolled
Cory Christiansen, PT PHDPrincipal InvestigatorUniversity of Colorado, Denver

Media Library

Limb Load Biofeedback Training Intervention Clinical Trial Eligibility Overview. Trial Name: NCT05695911 — N/A
Amputation Research Study Groups: Limb Load Biofeedback Training Intervention, Attention Control Intervention
Amputation Clinical Trial 2023: Limb Load Biofeedback Training Intervention Highlights & Side Effects. Trial Name: NCT05695911 — N/A
Limb Load Biofeedback Training Intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT05695911 — N/A
~13 spots leftby Jan 2026
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