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Limb Load Biofeedback Training for Osseointegration (TOPLOAD Trial)

Q: What is the aggregate sum of participants involved in this venture?

Indeed, data posted on clinicaltrials.gov declares that this medical trial is currently enrolling patients. This study was initially advertised on January 30th 2023 and has been updated most recently on the 31st of the same month. The research group is looking for 25 participants across one site.

Q: Are there still openings for individuals to participate in this trial?

Affirmative. Clinicaltrials.gov illuminates that this medical research project, which was initially posted on January 30th 2023, is currently recruiting participants. A total of 25 people are expected to be accepted at one single site.

Q: What is the ultimate goal of this medical research?

Primarily, the researchers will assess Change in Cumulative Loading at Week 64. Additionally, they intend to evaluate participants' World Health Organization-Disability Assessment Schedule 2.0 scores (which range from 0-100), Activities Specific Balance Confidence Scale ratings (ranging between 0%-100%), and Prosthetic Limb Users Survey of Mobility scores (12 points to 60 points) as secondary outcomes.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 5, week 24 and week 64

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.

Do I qualify?Apply below to find out

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Who is running the clinical trial?

University of Colorado, DenverLead Sponsor

1,738 Previous Clinical Trials

2,149,501 Total Patients Enrolled

United States Department of DefenseFED

865 Previous Clinical Trials

327,674 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the aggregate sum of participants involved in this venture?

"Indeed, data posted on clinicaltrials.gov declares that this medical trial is currently enrolling patients. This study was initially advertised on January 30th 2023 and has been updated most recently on the 31st of the same month. The research group is looking for 25 participants across one site."

Answered by AI

Are there still openings for individuals to participate in this trial?

"Affirmative. Clinicaltrials.gov illuminates that this medical research project, which was initially posted on January 30th 2023, is currently recruiting participants. A total of 25 people are expected to be accepted at one single site."

Answered by AI

What is the ultimate goal of this medical research?

"Primarily, the researchers will assess Change in Cumulative Loading at Week 64. Additionally, they intend to evaluate participants' World Health Organization-Disability Assessment Schedule 2.0 scores (which range from 0-100), Activities Specific Balance Confidence Scale ratings (ranging between 0%-100%), and Prosthetic Limb Users Survey of Mobility scores (12 points to 60 points) as secondary outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training

2023. "Transfemoral Osseointegrated Prosthesis Limb-Load Symmetry Training". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05695911.