The Relationship Between Lost Extremity Percentage and Postural Control, Neck and Low Back Pain, Daily Living Activities, and Reaction Time in Individuals With Unilateral Upper Limb Amputation
This observational study aims to examine the relationship between the percentage of limb loss and functional outcomes in individuals with unilateral upper limb amputation. Upper limb amputation can affect posture, balance control, pain levels, daily living activities, hand function, and reaction time. However, limited research has investigated how the amount of limb loss influences these outcomes.
Participants between 18 and 65 years of age who use a myoelectric or bionic prosthesis will undergo a series of assessments. These assessments include measurements of postural control using a force platform, posture analysis, evaluation of neck and low back pain using a visual analog scale, daily living activities using a validated questionnaire, hand dexterity using the Box and Block Test, and reaction time using a visual stimulus device.
The study does not involve any intervention or treatment. All evaluations will be performed during a single assessment session. The results of this study may help improve rehabilitation planning and provide better understanding of functional changes associated with different levels of limb loss in people with upper limb amputation.
調査の概要
状態
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：ASLI BEBEK, MSc
- 電話番号：+905364037230
- メール：aslisabanci97@gmail.com
研究場所
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Ankara、トルコ（Türkiye）
- 募集
- Hacettepe University
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コンタクト：
- aslı bebek, MSc
- 電話番号：+905364037230
- メール：aslisabanci97@gmail.com
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-
参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Adults aged 18-65 years
- Unilateral upper limb amputation
- Use of a myoelectric or bionic prosthesis for at least 1 year
- Current prosthesis use for a minimum of 3 months
Exclusion Criteria:
- Bilateral upper limb amputation
- Additional amputation of another limb
- Use of passive or cosmetic prosthesis
- Presence of neurological or other significant orthopedic disorders unrelated to amputation
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Unilateral Upper Limb Amputation Group
Participants in this cohort are adults aged 18 to 65 years with unilateral upper limb amputation who use a myoelectric or bionic prosthesis. Individuals must have been using their current prosthesis for at least three months and have a minimum of one year of prosthesis experience. Participants with additional neurological or orthopedic conditions, bilateral amputation, or passive/cosmetic prosthesis use are excluded. This is an observational study. No interventional procedures are performed. All participants undergo a single assessment session including measurements of postural control, posture, neck and low back pain, daily living activities, hand dexterity, and reaction time. |
This is an observational study.
No interventional procedures are performed.
All assessments are non-invasive measurements.
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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 |
|---|---|---|
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Daily living activity score
時間枠：through study completion, an average of 1 year
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In upper extremity amputees, daily living activities and occupational skills will be assessed using a questionnaire.
(0-100 score, Survey on Activities of Daily Living and Occupations of Upper Extremity Amputees)
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through study completion, an average of 1 year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Postural Sway and Limits of Stability
時間枠：through study completion, an average of 1 year
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Postural sway (cm) measured using a force BERTEC platform system.
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through study completion, an average of 1 year
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Postural Sway and Limits of Stability
時間枠：through study completion, an average of 1 year
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limits of stability (%) measured using a force BERTEC platform system.
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through study completion, an average of 1 year
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Neck and Back Pain Intensity
時間枠：through study completion, an average of 1 year
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Measured using the Visual Analog Scale (VAS) on a 0-10 scale, where 0 indicates no pain and 10 indicates the worst possible pain.
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through study completion, an average of 1 year
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Hand Dexterity
時間枠：through study completion, an average of 1 year
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easured using the Box and Block Test (number of blocks successfully transferred from one compartment to another in 60 seconds).
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through study completion, an average of 1 year
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Reaction Time
時間枠：through study completion, an average of 1 year
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Measured using the BlazePod system (recorded in milliseconds and the number of correct responses in 30 seconds).
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through study completion, an average of 1 year
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
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
- FTREK25/28
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。