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CompletedNCT06130917DPNUpdated May 7, 2024

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

An interventional study of Multisystem Exercise and Conventional Treatment in Diabetic Peripheral Neuropathy, sponsored by Riphah International University. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-05-07.

Sponsored by Riphah International University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
42
Allocation
Randomized
Ages
40 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed description

Diabetic peripheral neuropathy is a common and highly prevalent complication of type 2 diabetes mellitus, posing a significant global health concern. It affects a considerable number of individuals with diabetes, leading to progressive nerve damage and functional impairments. The multifaceted nature of this condition manifests in various ways, including sensory, motor, and autonomic dysfunction. Its insidious onset and gradual progression impose a substantial burden on patients, reducing their quality of life and presenting significant challenges for healthcare providers. Therefore, understanding the underlying causes, mechanisms, and management strategies of diabetic peripheral neuropathy is essential to alleviate its impact and enhance the overall well-being of those affected by this condition. Patients with diabetic peripheral neuropathy encounter a range of distressing symptoms that profoundly influence their daily activities. Sensory manifestations, such as numbness, tingling, and pain, are common, especially among older individuals with diabetes. Challenges in detecting temperature and touch also increase the risk of burns or injuries. Motor neuropathy results in muscle weakness, loss of balance, and coordination difficulties, making simple tasks like walking or holding objects more challenging. Furthermore, diabetic peripheral neuropathy plays a significant role in falls among elderly patients due to balance disorders and proprioception impairment. To address these issues and improve patients' quality of life, exercise has emerged as a valuable therapeutic intervention. Regular exercise programs, specifically those incorporating balance training exercises, have shown promising outcomes in enhancing balance and reducing falls among those with diabetic peripheral neuropathy. By emphasizing a comprehensive approach to exercise, targeting proprioception, coordination, and lower limb strength, patients can benefit from improved sensory integration, enhanced muscle control, and postural stability, ultimately promoting greater independence and reducing the risk of falls. Through a well-designed randomized controlled trial, exploring the effectiveness of a multisystem exercise program, further advancements in managing diabetic peripheral neuropathy can be achieved, leading to improved patient outcomes and enhanced quality of life.

02

Conditions studied

  • Diabetic Peripheral Neuropathy

Keywords

  • Balance, Multisystem Exercise, Peripheral neuropathy
03

In context

Peripheral Nervous System Diseases

1,003 studies on the registry are indexed under Peripheral Nervous System Diseases; 177 are open to participants now.

This study's enrollment of 42 is below the median of 60 across 768 interventional studies indexed under Peripheral Nervous System Diseases.

Browse Peripheral Nervous System Diseases studies →

Lead sponsor

Riphah International University is the lead sponsor of 2,133 studies on the registry; 633 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
42 participants (actual)

Study arms

  • Experimental
    Experimental Group

    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

  • Other
    Control group

    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

  • OtherMultisystem Exercise

    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

  • OtherConventional Treatment

    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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 8 weeks

  2. 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

    Time frame: 8 weeks

  3. 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.

    Time frame: 8 weeks

  4. 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

    Time frame: 8 weeks

  5. 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

    Time frame: 8 weeks

07

Study locations

1 site
  • DHQ Pakpattan
    Pakpattan, Punjab 57400, Pakistan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 7, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06130917
Lead sponsor
Riphah International University
Responsible party
Sponsor
First posted
Nov 14, 2023
Start date
Nov 5, 2023
Primary completion
Apr 5, 2024
Completion
Apr 10, 2024
Last update
May 7, 2024

Study contacts

Aruba Saeed, PhD*
principal investigator · Riphah International University Pakistan

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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