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Behavioural Intervention

Biofeedback for Knee Amputation

Q: Is it possible for me to join this clinical experiment?

Those who wish to take part in the trial must have chronic <a href="https://www.withpower.com/clinical-trials/back-pain">back pain</a> and be between 18-70 years old. 35 individuals are being sought for this research project.

Q: Has enrollment in this trial opened to the public yet?

The trial, which was initially uploaded to clinicaltrials.gov on September 15th 2021, is currently recruiting participants. The most recent revision of the protocol took place February 3rd 2022.

Q: What is the current enrollment size of this research study?

Affirmative. According to the information posted on clinicaltrials.gov, this experiment is currently looking for participants, with 35 needed between two trial sites. The trial was initially launched on September 15th 2021 and had its latest update of February 3rd 2022.

Q: Is this research study open to participants who are of legal age?

The age requirements for this medical trial only allow individuals aged 18 to 70 to participate.

Phase < 1

Recruiting

Research Sponsored by San Jose State University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Unilateral limb amputation occurring between the knee and hip joints

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 30 minutes

Awards & highlights

Study Summary

This trial is testing whether biofeedback is a feasible tool for gait retraining with above-knee prosthesis users.

Who is the study for?

This trial is for individuals who can walk for at least 25 minutes, have had an above-knee amputation between the knee and hip, are experienced with their current prosthetic for over three months, and are K2 or K3-level walkers. They must understand English and if they've had a vascular-related amputation, need a doctor's note to participate.Check my eligibility

What is being tested?

The study tests whether haptic biofeedback from the SageMotion system helps people with above-knee amputations improve walking patterns. Participants will receive vibrations on their skin during gait retraining to guide proper hip rotation. Their walking quality is assessed before, during, and after training.See study design

What are the potential side effects?

There may be minimal side effects related to wearing the biofeedback device such as skin irritation where it attaches or discomfort from the vibration feedback. However, these are expected to be mild.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have had one leg amputated between the knee and hip.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 30 minutes

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~30 minutes

This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 minutes for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Two-minute Walk Test (2MWT)

Secondary outcome measures

Gait Symmetry Indices (SIs)

Modified Gait Profile Score (mGPS)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Randomizing Control and Biofeedback PhasesExperimental Treatment1 Intervention

The gait training and data collection procedure is split into two phases: a control phase and a biofeedback phase. The order of these phases is randomized across participants to reduce the probability of systematic error due participants "warming-up" or fatiguing between trials. Each phase consists of a pre-test, gait retraining session, and one or more post-tests.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

San Jose State UniversityLead Sponsor

10 Previous Clinical Trials

1,906 Total Patients Enrolled

University of California, San FranciscoOTHER

2,505 Previous Clinical Trials

15,237,520 Total Patients Enrolled

VA Palo Alto Health Care SystemFED

87 Previous Clinical Trials

56,828 Total Patients Enrolled

Media Library

Haptic Biofeedback from SageMotion Biofeedback System (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05126485 — Phase < 1

Knee Amputation Research Study Groups: Randomizing Control and Biofeedback Phases

Knee Amputation Clinical Trial 2023: Haptic Biofeedback from SageMotion Biofeedback System Highlights & Side Effects. Trial Name: NCT05126485 — Phase < 1

Haptic Biofeedback from SageMotion Biofeedback System (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05126485 — Phase < 1

Frequently Asked Questions

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

Is it possible for me to join this clinical experiment?

"Those who wish to take part in the trial must have chronic back pain and be between 18-70 years old. 35 individuals are being sought for this research project."

Answered by AI

Has enrollment in this trial opened to the public yet?

"The trial, which was initially uploaded to clinicaltrials.gov on September 15th 2021, is currently recruiting participants. The most recent revision of the protocol took place February 3rd 2022."

Answered by AI

What is the current enrollment size of this research study?

"Affirmative. According to the information posted on clinicaltrials.gov, this experiment is currently looking for participants, with 35 needed between two trial sites. The trial was initially launched on September 15th 2021 and had its latest update of February 3rd 2022."

Answered by AI