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

13. května 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

42

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní záloha kontaktů

  • Jméno: Dr Muhammad Ateeb, PhD Public Health
  • Telefonní číslo: +92-3357333383
  • E-mail: mateeb.oric@tuf.edu.pk

Studijní místa

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

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Singl

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Jiný: 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.
Aktivní komparátor: 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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Static and dynamic balance
Časové okno: 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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Reactive balance
Časové okno: 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
Časové okno: 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

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

University of Faisalabad

Vyšetřovatelé

  • Vrchní vyšetřovatel: Dr Maryam Safdar, MS (MSK), The University of Faisalabad

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

20. května 2026

Primární dokončení (Odhadovaný)

20. září 2026

Dokončení studie (Odhadovaný)

20. září 2026

Termíny zápisu do studia

První předloženo

13. května 2026

První předloženo, které splnilo kritéria kontroly kvality

13. května 2026

První zveřejněno (Aktuální)

20. května 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

20. května 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

13. května 2026

Naposledy ověřeno

1. května 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • TUF/EIRB/172/26

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

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Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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