AmputationNCT03411148
Targeting Balance Confidence to Increase Community Integration in Users of Prostheses
A study testing Weekly exercise sessions with physical therapist and psychologist and Home-based exercises in people with Amputation and Physical Activity, run by Rosalind Franklin University of Medicine and Science at 2 sites in United States.
Trial summary
Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living. It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Physical Activity
- What is being tested?
- Weekly exercise sessions with physical therapist and psychologist and Home-based exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 2 sitesUnited States
- Study dates
- 5 Apr 2018to 1 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥18 years
- unilateral lower limb amputation without serious complications
- at least 6 months experience using a definitive lower limb prosthesis
- Activity Specific Balance Confidence (ABC) scale score≤80
- self-reported concern about balance that limit activities
Who cannot join
- active wounds on weight bearing surfaces
- inability to perform the protocol without an assistive device
- currently seeing a physical therapist for any reason
- history of neurodegenerative disease
- history of stroke
- ill-fitting or ill-functioning prosthesis (to be verified by research prosthetist during screening)
- prohibited by primary care physician or research physician to participate in mild exercise
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Captain James A. Lovell Federal Health Care Center
North Chicago, Illinois, 60064
Rosalind Franklin University of Medicine and Science
North Chicago, Illinois, 60064
About this study
Official title: Targeting Balance Confidence as a Strategy to Increase Integration and Improve Outcomes in Users of Lower-Limb Prostheses
Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living. It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation. Balance confidence is not necessarily related to functional abilities. It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence. Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities. The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.
Read the detailed description
Lower limb prosthesis users, with self-reported low balance confidence complete baseline gait analysis and balance testing, as well as a series of validated self-reported outcome scales addressing balance confidence, quality of life, and community integration. Participants are then provided a step activity monitor (SAM) and a global position sensing (GPS) tracker to be worn for one week, the data from which is linked and used to objectively quantify baseline community participation. At the conclusion of the one week, participants are randomized to one of two groups, each of which will last for 8 weeks. At the conclusion of the eight weeks, participants repeat baseline assessments and are again provided a SAM and GPS tracker to wear for one week. Baseline measures and activity monitoring occur again 8 and 16 weeks thereafter.
- Conditions
- Amputation, Physical Activity
- Being tested
- Weekly exercise sessions with physical therapist and psychologist, Home-based exercises
- Keywords
- fear avoidance, cognitive behavioral therapy, physical therapy, prosthetic, fear of falling, gait
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weekly exercise sessions with physical therapist and psychologistBehavioural
Eight weekly sessions integrating techniques from physical therapy and cognitive behavioral therapy. At the start of each session participants play virtual reality games that target balance and functional gait and then discuss their balance confidence and activity avoidance behaviors with a behavioural counselor. Weekly homework assignments ask participants to report on thoughts causing them to avoid activities and to slowly engage in activities that present increasing levels of fear.
Home-based exercisesBehavioural
Stretching and other exercises are safely taught by physical therapist and then practiced at home following a provided schedule. Participants receive periodic calls to discuss progress.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Group A | Experimental | Weekly exercise sessions with physical therapist and psychologist Receives: Behavioral: Weekly exercise sessions with physical therapist and psychologist |
| Exercise Group B | Placebo comparator | Home-based exercises Receives: Behavioral: Home-based exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Community integration
number of steps taken outside of the home
Measured: 24 weeks
Secondary outcomes (7)
Social Functioning scale from the 36-item Short Form Health Survey
The scale measures the extent to which physical and emotional problems interfere with social activities on a scale of 0-100 with higher scores indicating less interference
Measured: 24 weeks
Role Limitation due to Emotional Problems scale from the Short Form Health Survey (SF36)
The scale measures the extent to which emotional problems interfere with work and daily activities on a scale of 0-100 with higher scores indicating less interference
Measured: 24 weeks
Extent of Participation scale from the Measure of Community Reintegration of Servicemembers
The scale measures community participation in terms of how often an individual engages in certain activities on a score of 10-70 with higher scores indicating greater participation
Measured: 24 weeks
Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers
The scale measures self-perceived limitations in community participation n a score of 10-70 with higher scores indicating less limitation
Measured: 24 weeks
Frenchay Activity Index
This is a behavioral scale that primarily measures social participation, as well as daily activities on a score of 0-45 with higher scores indicating greater social activity.
Measured: 24 weeks
Change from baseline in Activity-specific balance confidence scale following the intervention
The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence
Measured: 8 weeks
Activity-specific balance confidence scale
The ABC scale measures balance confidence on a scale of 0-100 with higher values indicating greater confidence. Measurement at this time point will indicate the lasting impact of the intervention on balance confidence
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2018
- Study start5 Apr 2018
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for AmputationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rosalind Franklin University of Medicine and Science
- Sponsor type
- University, hospital or other
- Collaborators
- Northwestern University, Captain James A. Lovell Federal Health Care Center
- Responsible party
- Principal investigator, Noah Rosenblatt, Rosalind Franklin University of Medicine and Science
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03411148
- Sponsor's protocol ID
- OP160044
- Other IDs
- W81XWH-17-1-0697
- Status last verified
- May 2022
- First submitted
- 10 Jan 2018
- Last updated
- 1 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rosenblatt NJ, Schneider KL, Miller SA, Hagopian K, Hagg S, Reddin C, Churchill R, Dams GM, Calamari JE, Stachowiak A, Major MJ. Mixed methods analysis of an interdisciplinary intervention to promote balance confidence in lower limb prosthesis users. Front Rehabil Sci. 2025 Sep 1;6:1626051. doi: 10.3389/fresc.2025.1626051. eCollection 2025.
PubMed 40959746B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
PubMed 37276273Bourque MO, Schneider KL, Calamari JE, Reddin C, Stachowiak A, Major MJ, Duncan C, Muthukrishnan R, Rosenblatt NJ. Combining physical therapy and cognitive behavioral therapy techniques to improve balance confidence and community participation in people with unilateral transtibial amputation who use lower limb prostheses: a study protocol for a randomized sham-control clinical trial. Trials. 2019 Dec 30;20(1):812. doi: 10.1186/s13063-019-3929-8.
PubMed 31888708
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting Balance Confidence as a Strategy to Increase Integration and Improve Outcomes in Users of Lower-Limb Prostheses
- ClinicalTrials.gov ID
- NCT03411148
- Acronym / sponsor ID
- OP160044
- Conditions
- Amputation, Physical Activity
- Keywords
- fear avoidance, cognitive behavioral therapy, physical therapy, prosthetic, fear of falling, gait
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Rosalind Franklin University of Medicine and ScienceUniversity, hospital or other
- Collaborators
- Northwestern University, Captain James A. Lovell Federal Health Care Center
- Study start
- 5 Apr 2018 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 26 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Low balance confidence occurs when an individual perceives they have limited ability to maintain their balance while performing a specific task of daily living. It is a prevalent problem in lower limb prosthesis users and is a strong predictor of prosthesis use and community participation. Balance confidence is not necessarily related to functional abilities. It is possible to improve functional ability as a result of rehabilitation, without concurrently improving balance confidence. Interventions to address low balance confidence may need to target both functional abilities as well as beliefs regarding these abilities. The purpose of this study is to test whether, for users of lower limb prostheses, an intervention combining physical therapy exercise to improve function with cognitive behavioral therapy to address fears and thoughts associated with low confidence can improve balance confidence and promote community participation.
Detailed description
Lower limb prosthesis users, with self-reported low balance confidence complete baseline gait analysis and balance testing, as well as a series of validated self-reported outcome scales addressing balance confidence, quality of life, and community integration. Participants are then provided a step activity monitor (SAM) and a global position sensing (GPS) tracker to be worn for one week, the data from which is linked and used to objectively quantify baseline community participation. At the conclusion of the one week, participants are randomized to one of two groups, each of which will last for 8 weeks. At the conclusion of the eight weeks, participants repeat baseline assessments and are again provided a SAM and GPS tracker to wear for one week. Baseline measures and activity monitoring occur again 8 and 16 weeks thereafter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise Group A | Experimental | Behavioral: Weekly exercise sessions with physical therapist and psychologistWeekly exercise sessions with physical therapist and psychologist |
| Exercise Group B | Placebo comparator | Behavioral: Home-based exercisesHome-based exercises |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- age ≥18 years
- unilateral lower limb amputation without serious complications
- at least 6 months experience using a definitive lower limb prosthesis
- Activity Specific Balance Confidence (ABC) scale score≤80
- self-reported concern about balance that limit activities
Key exclusion criteria (7 listed)
- active wounds on weight bearing surfaces
- inability to perform the protocol without an assistive device
- currently seeing a physical therapist for any reason
- history of neurodegenerative disease
- history of stroke
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 |
|---|---|---|
| Weekly exercise sessions with physical therapist and psychologistEight weekly sessions integrating techniques from physical therapy and cognitive behavioral therapy. At the start of each session participants play virtual reality games that target balance and functional gait and then discuss their balance confidence and activity avoidance behaviors with a behavioural counselor. Weekly homework assignments ask participants to report on thoughts causing them to avoid activities and to slowly engage in activities that present increasing levels of fear. | Behavioural | Exercise Group A |
| Home-based exercisesStretching and other exercises are safely taught by physical therapist and then practiced at home following a provided schedule. Participants receive periodic calls to discuss progress. | Behavioural | Exercise Group B |
Primary outcome
Community integration
Time frame: 24 weeks
number of steps taken outside of the home
7 secondary outcomes
Social Functioning scale from the 36-item Short Form Health Survey
Time frame: 24 weeks
Role Limitation due to Emotional Problems scale from the Short Form Health Survey (SF36)
Time frame: 24 weeks
Extent of Participation scale from the Measure of Community Reintegration of Servicemembers
Time frame: 24 weeks
Perceived Limitation scale from the Measure of Community Reintegration of Servicemembers
Time frame: 24 weeks
Frenchay Activity Index
Time frame: 24 weeks
Change from baseline in Activity-specific balance confidence scale following the intervention
Time frame: 8 weeks
Activity-specific balance confidence scale
Time frame: 24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2022.
- Derived from this study: PubMed 40959746Rosenblatt NJ, Schneider KL, Miller SA, Hagopian K, Hagg S, Reddin C, Churchill R, Dams GM, Calamari JE, Stachowiak A, Major MJ. Mixed methods analysis of an interdisciplinary intervention to promote balance confidence in lower limb prosthesis users. Front Rehabil Sci. 2025 Sep 1;6:1626051. doi: 10.3389/fresc.2025.1626051. eCollection 2025.
- Derived from this study: PubMed 37276273B Aledi L, Flumignan CD, Trevisani VF, Miranda F Jr. Interventions for motor rehabilitation in people with transtibial amputation due to peripheral arterial disease or diabetes. Cochrane Database Syst Rev. 2023 Jun 5;6(6):CD013711. doi: 10.1002/14651858.CD013711.pub2.
- Derived from this study: PubMed 31888708Bourque MO, Schneider KL, Calamari JE, Reddin C, Stachowiak A, Major MJ, Duncan C, Muthukrishnan R, Rosenblatt NJ. Combining physical therapy and cognitive behavioral therapy techniques to improve balance confidence and community participation in people with unilateral transtibial amputation who use lower limb prostheses: a study protocol for a randomized sham-control clinical trial. Trials. 2019 Dec 30;20(1):812. doi: 10.1186/s13063-019-3929-8.
Related trials for Amputation
RecruitingObservational study
Usability of the Smart Hallway System in Clinical Setting
Amputation, Gait Disorders, Neurologic
Active, not recruiting
Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial Amputees
Amputation
Enrolling by invitation
Early Rehabilitation After Transfemoral Amputation in Moderately Active Patients Using the Avior Knee
Transfemoral Amputees
Recruiting
Hemocoll, Avitene, or Bone Wax for Cancellous Bone Bleeding After Single-Ray Amputation
Hemostasis, Surgical Blood Loss
Not yet recruitingPhase 4
Role of Perineural Catheter in Pain Control and Opioid Consumption After Major Amputation of Lower Limb
Lower Limb Surgery, Pain
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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Weekly exercise sessions with physical therapist and psychologist and Home-based exercises in people with Amputation and Physical Activity, run by Rosalind Franklin University of Medicine and Science at 2 sites 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 5 inclusion and 7 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 1 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Community integration (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03411148, which also lists 3 linked publications.
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 1 Jun 2022.