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.
調査の概要
詳細な説明
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.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
-
-
West Midlands
-
Birmingham、West Midlands、イギリス、B7 4BN
- Clive Thursfield
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 主な目的:デバイスの実現可能性
- 割り当て:なし
- 介入モデル:単一グループの割り当て
- マスキング:なし(オープンラベル)
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的: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.
|
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
User experience
時間枠: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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Adverse events
時間枠:1 week
|
To assess the introduction of new risks to the patient as a result of the adaptation
|
1 week
|
協力者と研究者
捜査官
- 主任研究者:Sarahjane Jones, PhD、Honorary contract - Birmingham Commnity Healthcare NHS Foundation Trust (substantive post with Birmingham City University)
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 216488
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
転倒によるけがの臨床試験
-
Zagazig University積極的、募集していないGrade III Traumatic Splenic Injury in Hemodynamically Stable Patientsエジプト
Step Right Buddyの臨床試験
-
Comenius UniversityNational Institute of Children's Diseases, Slovakia; Scientific Grant Agency (VEGA) of Slovakia募集
-
Brown UniversityNational Institute on Aging (NIA)完了
-
Dana-Farber Cancer InstituteNational Cancer Institute (NCI)完了
-
Glostrup University Hospital, CopenhagenRigshospitalet, Denmark積極的、募集していない
-
University of ManitobaVictoria General Hospital Foundation; Reh-Fit Fitness Centre; Wellness Institute-Seven Oaks General...引きこもった
-
Government College University Faisalabad募集
-
Parkinson's Disease Research, Education, and Clinical...完了
-
University of Leicester完了