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

Not Applicable

Recruiting

• Conditions: Diabetic Neuropathies; Mobility; Fall
• Interventions: Other: modified otago exercises; Other: Action Observation Training

• Registration Number: NCT06459375
• Lead Sponsor: Riphah International University

Brief Summary

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

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 Timeline

• Study Start: 2024-05-01
• Status Verified: 2024-06
• Study First Submitted: 2024-06-11
• Study First Submitted QC: 2024-06-11
• Last Update Submitted: 2024-06-11
• Study First Posted: 2024-06-14
• Last Update Posted: 2024-06-14
• Primary Completion: 2024-09-01
• Study Completion: 2024-09-15

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Modified Otago exercise group	modified otago exercises	patients in this group will receive modified Otago exercises with conventional treatment.
Action Observation Training group	Action Observation Training	patients in this group will receive Action Observation Training with conventional treatment.

Primary Outcome Measures

Name	Time	Method
Michigan neuropathy screening instrument (MNSI)	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)
The timed up and go test	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
30 second chair stand test	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.
Fall Efficacy Scale International:	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.

Trial Locations

Locations (1)

Riphah International University; 🇵🇰 Islamabad, Fedral, Pakistan