- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03419845
Frequent Fallers' Experiences of an Adapted Walking Frame, Designed to Reduce the Walking Aid's Associated Falls Risk (Walker)
A Pilot Investigation Into Frequent Fallers' Experiences of an Adapted Walking Frame, Designed to Reduce the Walking Aid's Associated Falls Risk
For some patients with mobility issues, a walking frame (commonly known as a zimmer frame - trademark of Zimmer Holdings), is provided to keep them on their feet and help them remain more independent in their home and when out and about. When patients are given the walking frame, they are given information on how to use it safely to protect them from hurting themselves. For a small group of patients, using the walking frame is difficult, and they will have a fall because they are unable to use the frame safely. For these patients, a fear of falling can then develop and they can then have more falls. It is thought that these falls with the walking frame happen because the patient steps too far into the frame, making them unstable. We have made an attachment for a standard walking frame, which we are calling the Step Right Buddy, that we think will help improve the stability of patients who step too far into the frame. We have attached a detachable elasticated band across the back legs of the frame to make patients aware that they have stepped far enough into the frame, to stop them stepping any further. In order to develop this further, we need to understand how people feel using this adapted frame and whether there are any new risks to the user.
The investigators propose to ask patients who are considered to be at risk of falling because of the way they use their walking frame if they would like to use the adapted walking frame in their home, instead of their standard frame, for a week. At the end of this week, investigators will spend up to an hour with this patient, talking with them about their experience of the adapted walking frame, in order to understand things such as how they felt using the frame, were they more or less fearful of using it than their usual frame, did they think they were going to fall over more or less often, do they think they fall more or less often. In addition to this, patients will keep a written record of when they thought they nearly fell, or when they had an injury whilst using the adapted walking frame. This information will be used to explore whether or not the adaption to the frame introduces new risks to patients.
Study Overview
Detailed Description
Title: A pilot investigation into frequent fallers' experiences of an adapted walking frame, designed to reduce the walking aid's associated falls risk.
Short title: The Walker Study
Chief Investigator: Dr Sarahjane Jones
Objectives:
To qualitatively explore the user's experience of the Step Right Buddy after a one week pilot trial and to assess the introduction of new risks to the patient as a result of the adaptation.
Trial configuration:
Qualitatively assessed clinical trial of a novel product.
Setting: Community care - patient homes.
Sample size: 20
Description of intervention: Application of the Step Right Buddy to the standard walking frame for patients to use as normal at home for one week.
Study duration:
Project length: March 2017 - July 2017
Length of participation - 1 week from consent
Randomisation and blinding: Single arm, open trial
Outcome measures: Participants' experiences of using the Step Right Buddy and adverse event data.
Analysis techniques: Framework analysis of textual data regarding the participants experiences and, where appropriate, root cause analysis of adverse events.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
West Midlands
-
Birmingham, West Midlands, United Kingdom, B7 4BN
- Clive Thursfield
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Purposively sampled as those identified as 'fallers' as a result of their use of the walking frame or at risk of falling currently on the case load of the rehabilitation team within Birmingham Community Healthcare NHS Trust
- Routinely use walking frame to manoeuvre around the house and/or outside
- 18 years old or greater (no upper age limit)
- Have no visual impairments
- Must have mental capacity to consent for themselves
- Must speak, read and comprehend English to participate in the interview
Exclusion Criteria:
- This are not perceived to be at risk of falling as a result of their use of the walking frame
- Are younger than 18 years of age
- Are visually impaired
- Do not have mental capacity to consent for themselves
- Cannot comprehend written and spoken English sufficiently to give informed consent
- Are unable to follow the safety instructions for using the Step Right Buddy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Step Right Buddy arm
To use modified walking frame using the Step Right Buddy
|
The Step Right Buddy, which is under investigation in this clinical study, is an elasticated band that attached by Velcro to the back legs of a standard walking frame.
The purpose of the Step Right Buddy is to provide sensory feedback to standard walking frame users of how far to step in to the frame and to encourage them to move the frame forward.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
User experience
Time Frame: 1 week
|
User experience will be assessed by asking the patient to trial the attachment for one week, completing a risk form during this week and providing verbal feedback at the end of this week.
|
1 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Adverse events
Time Frame: 1 week
|
To assess the introduction of new risks to the patient as a result of the adaptation
|
1 week
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Sarahjane Jones, PhD, Honorary contract - Birmingham Commnity Healthcare NHS Foundation Trust (substantive post with Birmingham City University)
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 216488
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Falls Injury
-
Massachusetts General HospitalCrico; Inspiren Inc; RGI Informatics LLCNot yet recruitingFalls and Falls With Injury
-
Brigham and Women's HospitalNational Institutes of Health (NIH); National Institute on Aging (NIA)RecruitingFall Injury | Falls | Exercise Self-Efficacy | Falls Self-EfficacyUnited States
-
Oregon Health and Science UniversityNot yet recruiting
-
Assistance Publique - Hôpitaux de ParisInstitut National de la Santé Et de la Recherche Médicale, France; Institut... and other collaboratorsCompletedFractures | Accidental Falls | Fall-related InjuriesFrance
-
Masimo CorporationCompletedFalls Injury | Pressure Ulcer | Pressure InjuryUnited States
-
National University, SingaporeRecruitingFalls Prevention | Falls RiskSingapore
-
The Hospital District of SatakuntaCompleted
-
University Hospital, Basel, SwitzerlandCompletedAccidental Falls | Underlying Disease of FallsSwitzerland, Germany
-
Lehigh Valley HospitalCompletedAccidental Falls | Falling Injury | Other and Unspecified Fall on Same LevelUnited States
-
The University of Texas Health Science Center,...Texas Woman's UniversityCompletedTraumatic Brain Injury | Acquired Brain Injury | Accidental FallsUnited States
Clinical Trials on Step Right Buddy
-
Radboud University Medical CenterDutch Cancer SocietyRecruiting
-
University of California, IrvineNational Cancer Institute (NCI); American Cancer Society, Inc.Recruiting
-
University Medical Center GroningenNot yet recruiting
-
Boston Medical CenterNational Cancer Institute (NCI); Northeastern UniversityCompletedPatient Satisfaction | Patient Compliance | Guideline AdherenceUnited States
-
The University of Texas at ArlingtonUniversity of South Florida; Center for Transportation, Equity, Decisions and...CompletedLack of Resources | Lack of MobilityUnited States
-
Sally CHANCompleted
-
Wolfson Medical CenterUnknown
-
University GhentResearch Foundation FlandersCompletedPhysical Activity | Intellectual Disability | Health Promotion | AdolescentsBelgium
-
University of California, Los AngelesBodiMojo, Inc.CompletedIrritable Bowel Syndrome | Abdominal PainUnited States
-
Cairo UniversityRecruitingPulmonary Disease, Chronic ObstructiveEgypt