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

NCT06459375 | Completed DMC

• 1 other identifier: REC/RCR & AHS/23/0283
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathies; Mobility; Fall

Keywords

Diabetic Neuropathies; Mobility; Fall

Outcome Measures

Primary Outcomes (4)

• Michigan neuropathy screening instrument (MNSI)

  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

  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

  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:

  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

Study Arms (2)

Modified Otago exercise group

EXPERIMENTAL

patients in this group will receive modified Otago exercises with conventional treatment.

Other: modified otago exercises

Action Observation Training group

ACTIVE COMPARATOR

patients in this group will receive Action Observation Training with conventional treatment.

Other: Action Observation Training

Interventions

modified otago exercises OTHER

patients will receive modified Otago exercises with conventional treatment.

Modified Otago exercise group

Action Observation Training OTHER

Patients will receive Action Observation Training with conventional treatment.

Action Observation Training group

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Islamabad, Fedral, 44000, Pakistan

Location

Related Publications (3)

• Ferreira JP, Sartor CD, Leal AM, Sacco IC, Sato TO, Ribeiro IL, Soares AS, Cunha JE, Salvini TF. The effect of peripheral neuropathy on lower limb muscle strength in diabetic individuals. Clin Biomech (Bristol). 2017 Mar;43:67-73. doi: 10.1016/j.clinbiomech.2017.02.003. Epub 2017 Feb 9.

  PMID: 28213167 BACKGROUND

• Vratna E, Husakova J, Jarosikova R, Dubsky M, Woskova V, Bem R, Jirkovska A, Kralova K, Pyskova B, Lanska V, Fejfarova V. Effects of a 12-Week Interventional Exercise Programme on Muscle Strength, Mobility and Fitness in Patients With Diabetic Foot in Remission: Results From BIONEDIAN Randomised Controlled Trial. Front Endocrinol (Lausanne). 2022 Jul 5;13:869128. doi: 10.3389/fendo.2022.869128. eCollection 2022.

  PMID: 35865313 BACKGROUND

• Van Eetvelde BLM, Lapauw B, Proot P, Vanden Wyngaert K, Celie B, Cambier D, Calders P. The impact of sensory and/or sensorimotor neuropathy on lower limb muscle endurance, explosive and maximal muscle strength in patients with type 2 diabetes mellitus. J Diabetes Complications. 2020 Jun;34(6):107562. doi: 10.1016/j.jdiacomp.2020.107562. Epub 2020 Feb 24.

  PMID: 32122790 BACKGROUND

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• zeest hashmi, MSNMPT

  Riphah International University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: after randomization patients will be divided into two groups through computer generated number programme. Patients in group A will receive modified Otago exercises with conventional treatment. Patients in group B will receive Action Observation Training with conventional treatment

Study Record Dates

• First Submitted: June 11, 2024
• First Posted: June 14, 2024
• Study Start: May 1, 2024
• Primary Completion: September 1, 2024
• Study Completion: September 1, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)