Effects Of Otago Exercise Versus Multisensory Integration Training On Balance And Gait In Elderly With Diabetes (Balance - DM)
The goal of this clinical trial is to compare the effect of the Otago exercise and Multisensory integration training on balance and gait in the elderly with type 2 diabetes mellitus.
The main question it aims to answer is:
• Is there a significant difference between the effect of Otago exercise and Multisensory integration training on balance and gait in the elderly with type 2 diabetes mellitus? Researchers will compare Otago exercise to Multisensory integration training to know which one has the greatest benefit on balance &gait in the elderly with type2 diabetes.
Participants will be divided into 3 groups; each group takes a certain training program for 8 weeks:
- First group: Otago exercise group plus conventional treatment for neuropathy.
- Second group: Multisensory integration training group plus conventional treatment for neuropathy.
- Third group: control group takes only conventional treatment for neuropathy.
Přehled studie
Postavení
Podmínky
Detailní popis
Diabetes one of the most prevalent chronic non-communicable diseases. Diabetic peripheral neuropathy (DPN) is a prevalent complication of diabetes, affecting about 50% of diabetic patients.
DPN characterized by peripheral nerve dysfunction. It initially presents sensory symptoms like numbness and tingling, which may evolve into pain and heightened sensitivity. Subsequently, motor symptoms such as muscle weakness and coordination difficulties appear, potentially leading to muscle atrophy.
Due to all these changes affecting peripheral nerve function, the functions of the lower extremities will be disturbed, which facilitate normal posture and walking, resulting in a loss of somatosensation and proprioception. This decreased sensitivity in the feet leads to balance defects, particularly in elderly and diabetic individuals.
The Otago exercise program is effective in preventing falls in older adults by improving cognitive function, balance, strength, functional fitness, and recovery, while reducing costs. Furthermore, multisensory exercises enhance balance and mobility by targeting sensory systems, thus lowering fall risk compared to traditional methods focused on physical strength or motor skills.
Both interventions positively affect balance and mobility in older adults with type 2 diabetes, but direct comparisons of their effectiveness are limited. This study aims to fill that gap by evaluating two rehabilitation interventions, potentially aiding clinical decision-making by identifying the more effective option for enhancing postural stability and mobility.
Typ studie
Zápis (Odhadovaný)
Fáze
- Nelze použít
Kontakty a umístění
Studijní kontakt
- Jméno: Toka Adel Mohammed Fahmy, physiotherapist
- Telefonní číslo: +201064030561
- E-mail: pttokaadel@gmail.com
Studijní místa
-
-
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Zagazig, Egypt
- El-Qenayat Central Hospital
-
Kontakt:
- Toka Adel Mohammed Fahmy, physiotherapist
- Telefonní číslo: +201064030561
- E-mail: pttokaadel@gmail.com
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
- Ninety elderly Patients of both genders.
- Their age will range from 65 to 75th.
- They will be diagnosed with type 2 diabetes for 5 years or more.
- Patients with mild & moderate neuropathy will be included. (Based on the Toronto scale: -mild (6-8); moderate (9-11)
- Berg balance between (21 to <50) patients with mild &moderate risk of fall .
- Time up & go dual task: patient takes longer than 10 sec.
- HBA1C for these patients was ≥ 6.5% .
- BMI will range from (18: 29,9 kg/m2).
- Able to walk independently, with or without assistive devices.
Exclusion Criteria:
- Any musculoskeletal disorder affecting the lower limb (fracture of the lower limb, tumors, any infection, ligament injuries, foot injuries).
- Any other neurological disorder influences gait such as (stroke, Parkinson's disease, cerebellar dysfunction, ataxia, vestibular disorders)
- Any other cardiovascular disease (arrhythmia, cardiac pacemakers).
- Unstable proliferative retinopathy and visual impairments without correction.
- Non-diabetic neuropathy (inflammatory, autoimmune disease, infections, tumors, vitamin B12 deficiency, hypothyroidism, alcoholism, injury or pressure on the nerve).
- The use of medications significantly impacting postural control (e.g., sedatives).
- Vestibular system and Cognitive disorders.
- Uncontrolled hypertension.
- Common peroneal nerve injury.
- Orthostatic hypotension.
Studijní plán
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 |
|---|---|
|
Aktivní komparátor: Otago exercise group
Otago exercise plus conventional treatment for neuropathy.
for 3d/w for 8weeks.
|
Exercise program consisted of ( flexibilty - strengthening - balance ) exercise for elderly. Time of each session (50:60 min). For 3d/w for 8weeks.
conventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks
|
|
Aktivní komparátor: Multisensory integration training group
Multisensory integration training group with conventional treatment for neuropathy. for 3d/w for 8 weeks. |
conventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks
Multisensory integration training is a group of balance exercise depend on facilitating different sensory systems (visual-vestibular-propioception) Time for each session (50 min).
For 3d/w for 8weeks.
|
|
Aktivní komparátor: control group
Only conventional treatment for neuropathy For 3d/w for 8 weeks.
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conventional treatment for improving balance and gait problem associated with DPN For 3d/w for 8weeks
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
|
Balance: ( Time up & go test )dual task
Časové okno: From enrollment to the end of treatment at 8 weeks
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From enrollment to the end of treatment at 8 weeks
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Balance: Berg Balance Scale
Časové okno: From enrollment to the end of the treatment at 8 weeks
|
From enrollment to the end of the treatment at 8 weeks
|
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Gait speed (10m walk test)
Časové okno: From enrollment to the end of the treatment at 8 weeks
|
From enrollment to the end of the treatment at 8 weeks
|
Sekundární výstupní opatření
Měření výsledku |
Časové okno |
|---|---|
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Functional reach test.
Časové okno: From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
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Modified fall efficacy scale
Časové okno: From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
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Toronto clinical neuropathy score
Časové okno: From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Gehad Ali Abd-Elhasseb, Assistant Professor, Cairo University
- Vrchní vyšetřovatel: Fatma Younis Mahmoud Abd-Elsalam, Lecturer of Physical Therapy, Cairo University
- Vrchní vyšetřovatel: Eman Mohamed El-Sayed Deif, consultant internal medicine
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- balance exercise for elderly
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