Effects of Modified Otago Exercises in Individuals With Diabetic Neuropathy

NCT ID: NCT05691738

Last Updated: 2025-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-12-23

Study Completion Date

2023-12-31

Brief Summary

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The aim of the study is to investigate the effects of modified otago exercises on joint position sense, balance and physical fitness parameters in individuals with diabetic neuropathy. In addition aim of to examine the effects of exercise on metabolic variables and to gain exercise awareness in diabetic individuals.

Detailed Description

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Conditions

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Diabetes Mellitus, Type 2 Neuropathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
The physician who will evaluate the metabolic parametres will not know which arm the individual is in. İn addition, the participants will not know which arm they are in.

Study Groups

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Exercise Group

Information will be given about diabetes and its complications.Modified Otago Exercise will be applied by the physiotherapist.Participants will be given a home program

Group Type EXPERIMENTAL

Exercise Group

Intervention Type OTHER

The exercise group will be informed about diabetes and diabetes complications. A total of 16 sessions of 8 weeks, modified otago exercises will be applied individually by the research physiotherapist.Individuals will be allowed to walk at a moderate pace for at least 30 minutes 5 days a week (home program).

Control Group

Information will be given about diabetes and its complications.Participants will be given a home program

Group Type OTHER

Control Group

Intervention Type OTHER

The control group will be informed about diabetes and diabetes complications. Individuals will be allowed to walk at a moderate pace for at least 30 minutes 5 days a week (home program)

Interventions

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Exercise Group

The exercise group will be informed about diabetes and diabetes complications. A total of 16 sessions of 8 weeks, modified otago exercises will be applied individually by the research physiotherapist.Individuals will be allowed to walk at a moderate pace for at least 30 minutes 5 days a week (home program).

Intervention Type OTHER

Control Group

The control group will be informed about diabetes and diabetes complications. Individuals will be allowed to walk at a moderate pace for at least 30 minutes 5 days a week (home program)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals with Neuropathy Diagnosed with Type 2 Diabetes between the Ages of 40-65 Years
* Cooperative, able to take instructions (Mini Mental Test score of 24 and above)
* Able to walk independently
* With a Body Mass Index Below 40 Kg/M2
* Not Doing Regular Physical Activity for the Last 6 Months
* Voluntarily participated in the research

Exclusion Criteria

* Additional neurological problem other than neuropathy
* Any orthopedic or systemic problems that will prevent him from performing the exercises
* The presence of pathology related to the lower limb that occurred within the last 6 months (surgery, fracture, soft tissue injuries, etc.)
* Pregnant
* Vision problem that cannot be corrected with glasses or lenses
* Hearing loss that cannot be corrected with hearing aids
* Foot ulcer
* Patients who have been diagnosed with cancer and are receiving chemotherapy in this context
* With limitation of the range of motion of the joints of the lower extremities
Minimum Eligible Age

40 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karamanoğlu Mehmetbey University

OTHER

Sponsor Role lead

Ankara Yildirim Beyazıt University

OTHER

Sponsor Role collaborator

Responsible Party

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Ali CEYLAN

Lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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ALİ CEYLAN, MSc

Role: PRINCIPAL_INVESTIGATOR

Karamanoğlu Mehmetbey University

Ertuğrul DEMİRDEL, PhD

Role: STUDY_CHAIR

Ankara Yildirim Beyazıt University

Locations

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Karaman Provincial Health Directorate Karaman Training and Research Hospital

Karaman, Center, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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KMU-ACEYLAN-001

Identifier Type: -

Identifier Source: org_study_id

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