Comparative Effects of Perturbation-Based Balance Training on Firm Surface and Rolling Board for Diabetic Neuropathy Patients
2026年5月13日 更新者：Maryam Safdar、University of Faisalabad
The present study is designed to compare the effectiveness of perturbation-based balance training performed on two different surfaces, stable (firm surface) and unstable (rolling board), for enhancing static, dynamic, and reactive balance in individuals diagnosed with diabetic neuropathy.
This randomized clinical trial will recruit a total of 42 participants, with the sample size calculated using Epi Tool software.
A consecutive sampling technique will be implemented.
Eligible participants who fulfill the inclusion criteria will be randomly assigned into two equal groups (n = 21 each) through an online randomization method.
Participants in Group A will undergo perturbation-based balance exercises on a stable surface, whereas participants in Group B will receive similar training on a rolling board to introduce surface instability.
In addition to the primary intervention, both groups will receive contrast bath therapy as a standard baseline treatment.
Written as well as verbal informed consent will be obtained prior to participation.
The intervention protocol will span four weeks, consisting of three sessions per week on alternate days, resulting in a total of twelve treatment sessions.
The primary outcomes will focus on balance performance and fall risk.
These outcomes will be measured using the Berg Balance Scale, the Mini-Balance Evaluation Systems Test, and the Timed Up and Go test.
Screening for diabetic neuropathy will be carried out using the Michigan Neuropathy Screening Instrument.
Statistical analysis will be performed using SPSS version 23.
調査の概要
状態
まだ募集していません
詳細な説明
Diabetic peripheral neuropathy is one of the most prevalent complications associated with Type 2 Diabetes Mellitus.
It commonly presents with symptoms such as burning sensations, tingling, numbness, discomfort, and diminished sensation in the lower extremities, which significantly affect balance and functional mobility.
The present study is designed to compare the effectiveness of perturbation-based balance training performed on two different surfaces, stable (firm surface) and unstable (rolling board), for enhancing static, dynamic, and reactive balance in individuals diagnosed with diabetic neuropathy.
This randomized clinical trial will recruit a total of 42 participants, with the sample size calculated using Epi Tool software.
A consecutive sampling technique will be implemented.
Eligible participants who fulfill the inclusion criteria will be randomly assigned into two equal groups (n = 21 each) through an online randomization method.
Participants in Group A will undergo perturbation-based balance exercises on a stable surface, whereas participants in Group B will receive similar training on a rolling board to introduce surface instability.
In addition to the primary intervention, both groups will receive contrast bath therapy as a standard baseline treatment.
Written as well as verbal informed consent will be obtained prior to participation.
The intervention protocol will span four weeks, consisting of three sessions per week on alternate days, resulting in a total of twelve treatment sessions.
The primary outcomes will focus on balance performance and fall risk.
These outcomes will be measured using the Berg Balance Scale, the Mini-Balance Evaluation Systems Test, and the Timed Up and Go test.
Screening for diabetic neuropathy will be carried out using the Michigan Neuropathy Screening Instrument.
Statistical analysis will be performed using SPSS version 23.
研究の種類
介入
入学 (推定)
42
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Maryam Safdar Dr, MS Physical Therapy (MSK)
- 電話番号：+92-3217978088
- メール：maryamsafdar.DPT@tuf.edu.pk
研究連絡先のバックアップ
- 名前：Dr Muhammad Ateeb, PhD Public Health
- 電話番号：+92-3357333383
- メール：mateeb.oric@tuf.edu.pk
研究場所
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Punjab Province
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Faisalābad、Punjab Province、パキスタン、38000
- Madinah Teaching Hospital and Al Mahmood Physiotherapy Clinic, Faisalabad
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
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
いいえ
説明
Inclusion Criteria:
- Individuals with a confirmed clinical diagnosis of Type 2 diabetes (HbA1c ≥ 6.5%) (Bolen et al., 2016).
- Participants with a diabetes duration of more than 10 years (Grewal et al., 2015).
- Participants exhibiting signs and symptoms of diabetic peripheral neuropathy (such as numbness, tingling, burning, shooting or electric shock-like pain, and glove-and-stocking distribution), confirmed using the Michigan Neuropathy Screening Instrument with scores of 6-8 (patient version) and 2.5-4 (physical assessment) (Haque et al., 2022).
- Participants aged between 40 and 75 years (Rasool et al., 2024).
- Both male and female participants will be eligible for inclusion (Haleem et al., 2024).
- Participants currently using insulin-sensitizing medications (e.g., metformin, Diamicron, insulin).
- Participants who are able to stand and walk independently (Allin et al., 2020).
- Participants with a Berg Balance Scale score ranging from 25 to 40 (Phyu et al., 2022).
- Participants willing to provide informed consent (Lepesis et al., 2023).
Exclusion Criteria:
- Patients with a confirmed diagnosis of benign paroxysmal positional vertigo (BPPV) will be excluded (Daud et al., 2021).
- Those with cognitive deficits (such as dementia or Alzheimer's disease) that may interfere with comprehension or compliance with study procedures will not be included (Hatton et al., 2019).
- Individuals presenting with foot drop or other neurological disorders (e.g., stroke, myelopathy, or cerebellar ataxia) that could affect the study findings will be excluded (Khurshid et al., 2025).
- Patients who have recently undergone surgery, sustained trauma to the feet or lower limbs, or have any foot amputation will not be eligible (Collings et al., 2023).
- Individuals diagnosed with deep vein thrombosis or orthostatic hypotension will be excluded (Khurshid et al., 2025).
- Patients with active diabetic foot ulcers or notable musculoskeletal deformities (such as scoliosis or degenerative joint disease) will be excluded (Lepesis et al., 2023).
- Individuals with neuropathy unrelated to diabetes, including cases associated with alcohol use or Charcot-Marie-Tooth disease, will not be included.
- Participants taking medications that may provoke vertigo or disturb balance (for example, aspirin) will be excluded.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
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：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：Group A (Perturbation Based Training on Firm Surface)
Manual perturbations will be applied in four directions: right lateral, left lateral, forward, and backward.
Training will be performed in progressive positions, starting from sitting, advancing to kneeling, and then to standing.
Contrast bath therapy will be administered for a total duration of 20 minutes.
|
Manual perturbations will be applied in four directions: right lateral, left lateral, forward, and backward.
Training will be performed in progressive positions, starting from sitting, advancing to kneeling, and then to standing.
Each session will include two sets of perturbation training, 5 minutes per set and a 10-second rest interval provided between successive perturbations.
The intervention will be conducted three days per week on alternate days, with a total of 10 perturbations delivered per session.
Total treatment time will be 45 minutes.
Progression to more challenging positions will occur once the patient demonstrates adequate balance control following manual perturbations.
The total duration of the treatment program will be four weeks.
Contrast bath therapy will be administered for a total duration of 20 minutes.
The protocol will involve immersion in cold water (60-70°F) for 1 minute followed by warm water (100-105°F) for 3 minutes, repeated for five cycles.
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アクティブコンパレータ：Group B (Perturbation Based Training on Rolling Board)
Manual perturbations will be applied in multiple directions while the patient stands on a rolling board.
During the procedure, the therapist will manually perturb the rolling board to challenge the patient's balance.
Initially, the training will be conducted within parallel bars for safety and will later be progressed outside the bars as the patient's balance improves.
The total duration of the treatment program will be four weeks.
Contrast bath therapy will be administered for a total duration of 20 minutes.
|
Manual perturbations will be applied in multiple directions while the patient stands on a rolling board.
During the procedure, the therapist will manually perturb the rolling board to challenge the patient's balance.
Each session will consist of two sets of training, with each set lasting 5 minutes and a 10-second rest interval between successive perturbations.
The intervention will be performed three days per week on alternate days, with a total of 10 perturbations delivered per session.
Each treatment session will last approximately 45 minutes.
Initially, the training will be conducted within parallel bars for safety and will later be progressed outside the bars as the patient's balance improves.
The total duration of the treatment program will be four weeks.
Contrast bath therapy will be administered for a total duration of 20 minutes.
The protocol will involve immersion in cold water (60-70°F) for 1 minute followed by warm water (100-105°F) for 3 minutes, repeated for five cycles.
|
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 |
|---|---|---|
|
Static and dynamic balance
時間枠：Baseline and Week 4
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Static and dynamic balance will be measured using the standard Berg Balance Scale, a widely used clinical tool for assessing balance performance and fall risk.
It consists of 14 functional tasks, including sitting, standing, reaching, turning, and transferring, with each item scored on a 5-point scale from 0 to 4. Higher total scores indicate better balance ability.
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Baseline and Week 4
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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 |
|---|---|---|
|
Reactive balance
時間枠：Baseline and Week 4
|
The Mini-Balance Evaluation System Test (Mini-BESTest) will be used to assess reactive balance and postural control.
It evaluates different balance systems, including anticipatory adjustments, reactive responses, sensory orientation, and dynamic gait, through functional balance tasks.
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Baseline and Week 4
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Risk of Fall
時間枠：Baseline and Week 4
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The Timed Up and Go Test (TUG) will be used to assess functional mobility and fall risk.
In this test, participants are timed while standing up from a chair, walking 3 meters, turning, returning, and sitting down again, with longer completion times indicating greater fall risk.
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Baseline and Week 4
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- 主任研究者：Dr Maryam Safdar, MS (MSK)、The University of Faisalabad
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- Akbari NJ, Naimi SS. The effect of exercise therapy on balance in patients with diabetic peripheral neuropathy: a systematic review. J Diabetes Metab Disord. 2022 Jul 4;21(2):1861-1871. doi: 10.1007/s40200-022-01077-1. eCollection 2022 Dec.
- Phyu SN, Wanpen S, Chatchawan U. Responsiveness of the Mini-Balance Evaluation System Test in Type 2 Diabetic Patients with Peripheral Neuropathy. J Multidiscip Healthc. 2022 Dec 29;15:3015-3028. doi: 10.2147/JMDH.S392058. eCollection 2022.
- Nugraha MHS. Balance Problems in the Elderly with Diabetes Mellitus: A Literature Review. J Midlife Health. 2024 Apr-Jun;15(2):55-61. doi: 10.4103/jmh.jmh_29_23. Epub 2024 Jul 5.
- Lepesis V, Paton J, Rickard A, Latour JM, Marsden J. Effects of foot and ankle mobilisations combined with home stretches in people with diabetic peripheral neuropathy: a proof-of-concept RCT. J Foot Ankle Res. 2023 Dec 6;16(1):88. doi: 10.1186/s13047-023-00690-4.
- Khurshid S, Saeed A, Kashif M, Nasreen A, Riaz H. Effects of multisystem exercises on balance, postural stability, mobility, walking speed, and pain in patients with diabetic peripheral neuropathy: a randomized controlled trial. BMC Neurosci. 2025 Feb 27;26(1):16. doi: 10.1186/s12868-024-00924-6.
- Jiang X, Deng F, Rui S, Ma Y, Wang M, Deng B, Wang H, Du C, Chen B, Yang X, Boey J, Armstrong DG, Deng W, Duan X. The Evaluation of Gait and Balance for Patients with Early Diabetic Peripheral Neuropathy: A Cross-Sectional Study. Risk Manag Healthc Policy. 2022 Mar 30;15:543-552. doi: 10.2147/RMHP.S361698. eCollection 2022.
- Hatton AL, Gane EM, Maharaj JN, Burns J, Paton J, Kerr G, Rome K. Textured shoe insoles to improve balance performance in adults with diabetic peripheral neuropathy: study protocol for a randomised controlled trial. BMJ Open. 2019 Jul 17;9(7):e026240. doi: 10.1136/bmjopen-2018-026240.
- Haleem F, Saeed A, Kundi M, Jalal A, Bilal M, Jalal M. Combined effects of strength and balance training versus aerobic training on balance, neuropathy symptoms and quality of life in patients with diabetic peripheral neuropathy. Physiother Res Int. 2024 Jul;29(3):e2103. doi: 10.1002/pri.2103.
- Grewal GS, Schwenk M, Lee-Eng J, Parvaneh S, Bharara M, Menzies RA, Talal TK, Armstrong DG, Najafi B. Sensor-Based Interactive Balance Training with Visual Joint Movement Feedback for Improving Postural Stability in Diabetics with Peripheral Neuropathy: A Randomized Controlled Trial. Gerontology. 2015;61(6):567-74. doi: 10.1159/000371846. Epub 2015 Feb 19.
- Collings R, Freeman J, Latour JM, Hosking J, Paton J. Insoles to ease plantar pressure in people with diabetes and peripheral neuropathy: a feasibility randomised controlled trial with an embedded qualitative study. Pilot Feasibility Stud. 2023 Feb 3;9(1):20. doi: 10.1186/s40814-023-01252-y.
- Allin LJ, Brolinson PG, Beach BM, Kim S, Nussbaum MA, Roberto KA, Madigan ML. Perturbation-based balance training targeting both slip- and trip-induced falls among older adults: a randomized controlled trial. BMC Geriatr. 2020 Jun 12;20(1):205. doi: 10.1186/s12877-020-01605-9.
- Daud SAH, Rahman MU, Arsh A, Junaid M. Effect of balance training with Biodex Balance System to improve balance in patients with diabetic neuropathy: A quasi experimental study. Pak J Med Sci. 2021 Mar-Apr;37(2):389-392. doi: 10.12669/pjms.37.2.2336.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年5月20日
一次修了 (推定)
2026年9月20日
研究の完了 (推定)
2026年9月20日
試験登録日
最初に提出
2026年5月13日
QC基準を満たした最初の提出物
2026年5月13日
最初の投稿 (実際)
2026年5月20日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月20日
QC基準を満たした最後の更新が送信されました
2026年5月13日
最終確認日
2026年5月1日
詳しくは
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。