Effects of Modified Otago Versus Action Observation on Strength, Mobility and Fall Risk in Diabetic Neuropathy

June 11, 2024 updated by: Riphah International University

Comparative Effects of Modified Otago Exercises and Action Observation Training on Strength, Functional Mobility and Fall Risk in Patients With Diabetic Neuropathy

To compare the Effects of Modified Otago Exercise and Action Observation Training on strength, functional mobility and fall risk in patients with diabetic neuropathy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This study will be a randomized clinical trial. A total of 38 participants with diabetic neuropathy will be taken. By using non probability convenience sampling technique patients will be randomized and allocated into two intervention groups based on inclusion and exclusion criteria.Patients in group A will receive modified Otago exercises with conventional treatment.Patients in group B will receive Action Observation Training with conventional treatment.All participants will receive treatment of 40 minutes per session for 5 days a week for 8 weeks.The Michigan neuropathy screening instrument will be used for the assessment of diabetic neuropathy score.The strength,functional mobility and fall risk will be assessed by using 30 second chair stand test, Timed up and go test and fall efficacy scale.

Study Type

Interventional

Enrollment (Estimated)

38

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Pakistan
    • Fedral
      • Islamabad, Fedral, Pakistan, 44000
        • Recruiting
        • Riphah International University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Hafiza Laraib, MS NMPT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals with type 2 diabetes already diagnosed by physician from last 2 years
  • Able to take instructions

Exclusion Criteria:

  • Additional neurological problem Guillain barre syndrome, Parkinson disease, multiple sclerosis, other than neuropathy
  • Participant with visual, vestibular system and auditory problems
  • Participant with cardiovascular problem, cerebrovascular problem and epilepsy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Modified Otago exercise group
patients in this group will receive modified Otago exercises with conventional treatment.
Other: modified otago exercises
patients will receive modified Otago exercises with conventional treatment.
Active Comparator: Action Observation Training group
patients in this group will receive Action Observation Training with conventional treatment.
Other: Action Observation Training
Patients will receive Action Observation Training with conventional treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Michigan neuropathy screening instrument (MNSI)
Time Frame: 6 months
To determine neuropathy, Michigan neuropathy screening instrument (MNSI) developed by the researchers at the university of Michigan in 2000, used to diagnosed peripheral neuropathy. It includes two parts; section A is self-administered by the patient and assess the clinical symptoms through 15 Yes or No questions and section B is used on a clinical evaluation. The questionnaire inquiries about positive (pain, temperature sensation and tingling) and negative (numbness, sensory symptoms, cramps and muscle weakness, foot ulcer or cracks and amputation. Neuropathy can be defined as seven or more positive responses on the MNSI questionnaire. The test-retest reliability of the Turkish version of the MNSI was determined as 0.99 for the total score (intraclass correlation coefficient = 0.996)
6 months
30 second chair stand test
Time Frame: 6 months
30 second chair stand test assesses the leg strength and endurance in older adults.it is part of the stop elderly accidents, deaths, and injuries which was created by centers for Disease Control and Preventions a screening tool for senior belonging to the high fall risk group .it has excellent test-retest reliability r=0.89(95%confident interval 0.79-0.93)The test measures the number of times and older adults can get up from a chair with their arms crossed in front of their trunk(on the opposite shoulder crossed at the wrists)in 30 seconds.
6 months
The timed up and go test
Time Frame: 6 months
The timed up and go test is to identify mobility and balance. Patients sitting in a chair without armrest will be asked to stand up with the start command and walk the 3-meter distance, whose start and end points are specified before, turn around and sit on the chair again. The test will be repeated 3 times and the average time will be recorded. The TUG test showed excellent reliability (ICC>.95) The Timed -up and go‖ test showed good intrarater and interrater reliability (r = .93 ). less time taken by patient will be graded as good mobility
6 months
Fall Efficacy Scale International:
Time Frame: 6 months

Fall Efficacy Scale International:

It is a common test battery with 16 items that reveals the possibility of falling in patients. The total score ranges from 16 to 64, where 16 indicates NO concern and 64 indicates EXTREMELY concerned about falling during the performance of specific activities suggested by the questionnaire.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Riphah International University

Investigators

  • Principal Investigator: Zeest hashmi, MSNMPT, Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

September 15, 2024

Study Registration Dates

First Submitted

June 11, 2024

First Submitted That Met QC Criteria

June 11, 2024

First Posted (Actual)

June 14, 2024

Study Record Updates

Last Update Posted (Actual)

June 14, 2024

Last Update Submitted That Met QC Criteria

June 11, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REC/RCR & AHS/23/0283

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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