The Effect of Sensorial Biodex Balance Balance System Exercises in Diabetic Neuropathy

NCT ID: NCT05255497

Last Updated: 2022-03-11

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

27 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-02

Study Completion Date

2020-09-20

Brief Summary

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This study examined the effects of balance exercises performed with the Biodex Balance System (BBS) on nerve conduction, sensory symptoms, and muscle strength in patients with diabetes-related neuropathy.

Detailed Description

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We enrolled twenty-seven patients in this study. Patients in the intervention group (n=14) performed exercises using the computerized BBS. The control group (n=13) was just informed about diabetes self-management. All patients underwent pretest and posttest peripheral nerve conduction studies. Sensory examination performed by using 5.07 Semmes-Weinstein monofilaments and 128-Hz tuning fork. Muscle strength measurements obtained with manual dynamometer

Conditions

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Diabetic Neuropathies Diabetes Mellitus Exercise Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Biodex Balance Group

This group performed exercises using the biodex balance system

Group Type EXPERIMENTAL

Biodex Balance Exercise System

Intervention Type DEVICE

Patients in the intervention group (n=14) performed exercises using the computerized BBS. The control group (n=13) was just informed about diabetes self-management.

Control Group

This group was informed about diabetes self-management.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Biodex Balance Exercise System

Patients in the intervention group (n=14) performed exercises using the computerized BBS. The control group (n=13) was just informed about diabetes self-management.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* diabetes-related neuropathy based on laboratory tests, clinical findings, and nerve conduction study

Exclusion Criteria

* increased risk of non-diabetes related neuropathy: history of autoimmune, cerebrovascular, or chronic infectious disease, cancer, chemotherapy and/or radiotherapy, radicular neuropathy, chronic kidney and liver failure, alcoholism or other substance abuse, and mental or physical disabilities (including blindness). We also excluded patients who didn't speak Turkish
Minimum Eligible Age

45 Years

Maximum Eligible Age

76 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Duygu AKTAR REYHANIOGLU

OTHER

Sponsor Role lead

Responsible Party

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Duygu AKTAR REYHANIOGLU

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Gaye Yıldırım, Dr

Role: STUDY_CHAIR

Dokuz Eylul University

Locations

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Dokuz Eylul University

Izmir, Balcova/Incialtı, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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Reyhanioglu DA, Yildirim G, Sengun IS, Kara B. Effects of Computer-based Balance Exercises on Balance, Pain, Clinical Presentation and Nerve Function in Patients With Diabetic Peripheral Neuropathy: A Randomized Controlled Study. J Musculoskelet Neuronal Interact. 2024 Jun 1;24(2):168-177.

Reference Type DERIVED
PMID: 38825999 (View on PubMed)

Other Identifiers

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IzmirTinaztepeU

Identifier Type: -

Identifier Source: org_study_id

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