- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT07776535
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskeluyhteys
- Nimi: Toka Adel Mohammed Fahmy, physiotherapist
- Puhelinnumero: +201064030561
- Sähköposti: pttokaadel@gmail.com
Opiskelupaikat
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Zagazig, Egypti
- El-Qenayat Central Hospital
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Ottaa yhteyttä:
- Toka Adel Mohammed Fahmy, physiotherapist
- Puhelinnumero: +201064030561
- Sähköposti: pttokaadel@gmail.com
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-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Active Comparator: 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
|
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Active Comparator: 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.
|
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Active Comparator: 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
|
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Balance: ( Time up & go test )dual task
Aikaikkuna: 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
Aikaikkuna: 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)
Aikaikkuna: From enrollment to the end of the treatment at 8 weeks
|
From enrollment to the end of the treatment at 8 weeks
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
|---|---|
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Functional reach test.
Aikaikkuna: 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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Modified fall efficacy scale
Aikaikkuna: 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
Aikaikkuna: From enrollment to the end of treatment at 8 weeks
|
From enrollment to the end of treatment at 8 weeks
|
Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Päätutkija: Gehad Ali Abd-Elhasseb, Assistant Professor, Cairo University
- Päätutkija: Fatma Younis Mahmoud Abd-Elsalam, Lecturer of Physical Therapy, Cairo University
- Päätutkija: Eman Mohamed El-Sayed Deif, consultant internal medicine
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Arvioitu)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- balance exercise for elderly
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
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