Clinical trial NCT06459375: Effects of Modified Otago Versus Action Observation on Strength, Mobility and Fall Risk in Diabetic Neuropathy
Official title: Comparative Effects of Modified Otago Exercises and Action Observation Training on Strength, Functional Mobility and Fall Risk in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Mobility
Fall
Keywords: Diabetic Neuropathies
Mobility
Fall
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2024-06-14
Enrollment: 38
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Michigan neuropathy screening instrument (MNSI)
timeFrame: 6 months
measure: 30 second chair stand test
timeFrame: 6 months
measure: The timed up and go test
timeFrame: 6 months
measure: Fall Efficacy Scale International:
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International University
state: Fedral
Study officials:
affiliation: Riphah International University
name: zeest hashmi, MSNMPT
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.