Effects of Multisystem Exercise on Balance, Postural Stability, Mobility and Pain in Patients With DPN.

NCT06130917 | Completed DMC

• 1 other identifier: REC/0242 Sidra khurshid
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

Upto the best knowledge of researcher, multisystem exercise program has been utilized in various populations, encompassing both healthy individuals and patients with diverse medical conditions. However, its specific impact on the diabetic peripheral neuropathy population, particularly in terms of improving balance, postural stability and mobility remains inadequately explored.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Balance, Multisystem Exercise, Peripheral neuropathy

Outcome Measures

Primary Outcomes (5)

• Beg Balance Scale

  It is used to assess balance. Each item is a 5-point ordinal scale ranging from 0 to 4, with 0 indicating an inability to complete the task entirely and 4 indicating an ability to complete the task criterion. Scores can range from 0 to 56. Change will be measured from Baseline to 8 weeks.

  8 weeks

• Functional reach test

  It is a widely used clinical assessment tool to measure an individual's dynamic balance and stability. The test requires the participant to reach forward as far as possible without taking a step or losing balance. The distance reached is recorded and compared to normative values based on age and gender. score less than 6 indicates risk of fall. score between 6-10 indicates moderate risk of fall. Change will be measured from baseline to 8 weeks

  8 weeks

• Timed Up and Go test

  It is for the assessment of lower extremity function, mobility and fall risk. score more than 12 indicates risk of fall and walking problem. Change will be measured from Baseline to 8 weeks.

  8 weeks

• Ten meter walk test

  It is a performance measure used to assess walking speed in meters per second over a short distance. its value for adults between 40 to 60 ages ranges from 1.43 to 1.31 m/s. Change will be measured from Baseline to 8 weeks

  8 weeks

• Numeric pain rating scale

  Numeric Pain Rating Scale (NPRS) is used to assess the pain levels reported by participants. it ranges from 0 to 10, with 0 indicating no pain and 10 representing the most awful imaginable pain. Change will be measured from Baseline to 8 weeks

  8 weeks

Study Arms (2)

Experimental Group

EXPERIMENTAL

Experimental group will receive education on diabetes and conventional treatment exercises. The interventional multisystem exercises program will consist of four components, with each exercise lasting for a duration of 10 minutes per session. These components encompass proprioception training, balance exercises, strengthening routines, and reaction time training. This total multisystem exercises session will be performed for 30 minute, 3 times a week for 8 weeks in total.

Other: Multisystem Exercise

Control group

OTHER

Control group will receive health education on diabetes. Conventional treatment will include Stretching, Range of motion (ROM) exercise , balance and strengthening for 10 minutes each exercise in one session. Each stretch holds for 15-20 sec. This exercise session will be performed for 30 minute, 3 times a week for 8 weeks in total.

Other: Conventional Treatment

Interventions

Multisystem Exercise OTHER

Proprioception: Seated ankle ball. Single leg stance with support and with extension of knees. Single leg stance (hip extension) with support and with extension' of knees. Muscle strengthening: Seated alternate double knee lifts with weights, chair stands. Seated alternate kicks with weigh. Hip extension standing with support with weights. Balance Training Seated alternate weight shifts. Seated calf and toe raise. Heel raise with support.. Crossover with support Reaction time Seated alternate touches to front. Seated alternate touches to back. Seated alternate touches to side. Seated alternate touches to 3 steps (forward, side, backward).

Also known as: Experimental Group

Experimental Group

Conventional Treatment OTHER

ROM exercises Passive ROM exercise of hip. Passive ROM exercise of knee. Passive ROM exercise of ankle Muscle strengthening Seated alternate double knee lifts with weights. chair stands. Seated alternate kicks with weigh. Hip extension standing with support with weights. Balance Seated alternate weight shifts. Seated calf and toe raise. Heel raise with support. Crossover with support Stretching exercises Stretching exercise of hamstring. Stretching exercise of quadriceps. Stretching exercise of calf muscle

Also known as: Control Group

Control group

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Both genders (male, female)
• Age (40-60)
• Patients who are screened for diabetic peripheral neuropathy
• Moderate balance impairment on Berg Balance Scale (21-40)
• Patients who met the criteria of Diabetic Neuropathy 4 scored equal or greater than 4.
• Patients who have positive sharpened Romberg test

You may not qualify if:

• Patients with any recent surgery of lower limb
• Patients with crutches
• Patients with gangrene
• Patients with lower BMI
• patients with Deep Venous Thrombosis (DVT)
• patients with amputations
• Patients with neurological impairments in the central nervous system and vestibular system
• Patients with orthostatic hypotension

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

DHQ Pakpattan

Pakpattan, Punjab Province, 57400, Pakistan

Location

Related Publications (1)

• Khurshid S, Saeed A, Kashif M, Nasreen A, Riaz H. Effects of multisystem exercises on balance, postural stability, mobility, walking speed, and pain in patients with diabetic peripheral neuropathy: a randomized controlled trial. BMC Neurosci. 2025 Feb 27;26(1):16. doi: 10.1186/s12868-024-00924-6.

  PMID: 40016658 DERIVED

MeSH Terms

Conditions

Peripheral Nervous System Diseases

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Aruba Saeed, PhD*

  Riphah International University Pakistan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors will be kept blinded about the intervention which the patients will be going to receive.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 9, 2023
• First Posted: November 14, 2023
• Study Start: November 5, 2023
• Primary Completion: April 5, 2024
• Study Completion: April 10, 2024
• Last Updated: May 7, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)