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Comparative Effects of Perturbation-Based Balance Training on Firm Surface and Rolling Board for Diabetic Neuropathy Patients

2026년 5월 13일 업데이트: 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.

연구 개요

상태

아직 모집하지 않음

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (추정된)

42

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 파키스탄
    • Punjab Province
      • Faisalābad, Punjab Province, 파키스탄, 38000
        • Madinah Teaching Hospital and Al Mahmood Physiotherapy Clinic, Faisalabad

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 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.
다른: 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. 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.
활성 비교기: 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.
다른: 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. 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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Static and dynamic balance
기간: Baseline and Week 4
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.
Baseline and Week 4

2차 결과 측정

결과 측정
측정값 설명
기간
Reactive balance
기간: 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.
Baseline and Week 4
Risk of Fall
기간: Baseline and Week 4
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.
Baseline and Week 4

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Faisalabad

수사관

  • 수석 연구원: Dr Maryam Safdar, MS (MSK), The University of Faisalabad

간행물 및 유용한 링크

연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.

일반 간행물

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (추정된)

2026년 5월 20일

기본 완료 (추정된)

2026년 9월 20일

연구 완료 (추정된)

2026년 9월 20일

연구 등록 날짜

최초 제출

2026년 5월 13일

QC 기준을 충족하는 최초 제출

2026년 5월 13일

처음 게시됨 (실제)

2026년 5월 20일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 5월 20일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 5월 13일

마지막으로 확인됨

2026년 5월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • TUF/EIRB/172/26

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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