Comparative Effects of Balance and Resisted Training in Diabetic Peripheral Neuropathy.

NCT06303453 | Completed DMC

• 1 other identifier: REC/RCR&AHS/23/0291
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study is to determine comparative effects of balance and resisted training on pain and balance in patients with daibetic peripheral neuropathy.

Conditions

Diabetic Peripheral Neuropathy

Keywords

Diabetic Peripheral Neuropathy; Balance Training; Resisted Training; Pain Management; Rehabilitation Exercises

Outcome Measures

Primary Outcomes (3)

• Michigan neuropathy screening instrument

  This screening tool consists of two sections: Section A, self-administered by the patient, involves 15 yes/no questions about clinical symptoms, and Section B is based on a clinical evaluation. Positive and negative sensory symptoms, cramps, muscle weakness, foot ulcers, cracks, and amputation are assessed.

  8th week

• De Morton mobility index test

  It consists of 15 items covering a broad spectrum of mobility levels and it has shown satisfactory Clinometric properties (30). In this method, the static balance is measured on one leg and two legs, as well as at the closing of the eyes; on the other hand, the dynamic balance is measured and evaluated when the patient jumps and moves four steps back.

  8th week

• PainDETECT Tool

  painDETECT scale to detect diabetic neuropathic pain which includes symptom questioning and also the type, severity and the radiation of pain.

  8th week

Study Arms (2)

GROUP A (BALANCE EXERCISES)

EXPERIMENTAL

Group A will receive a session of balance exercises for 45 minutes.Treatment session will be given for 3 days per week for 8 weeks.This balance exercise program consist of three phases.Warm-up phase(5 minutes,after warm-up phase 35 minutes balance exercises then cooling phase (5 minutes).

Other: Balance exercises

GROUP B (RESISTED EXERCISES)

EXPERIMENTAL

Group B will receive a session of resisted exercises for 45 minutes.Treatment session will be given for 3 days per week for 8 weeks.This resisted exercises program consist of three phases.Warm-up phase(5 minutes,after warm-up phase 35 minutes balance exercises then cooling phase (5 minutes).

Other: Resisted exercises

Interventions

Balance exercises OTHER

Balance exercises includes active movements (flexion, extension, abduction, adduction) of one upper extremity and lower extremity, trunk movements (bending forward and rotation), raising heel, raising toes and raising heel. Every move in each session will be hold for 30 seconds. The part B comprises of training i.e., holding positions in standing posture which include moving the ball up and down in a straight line with two upper extremities, moving the ball up and down in an oblique line with two upper extremities, moving the ball forward and backward with left and right lower extremities, moving the ball laterally with left and right lower extremities, throwing the ball against the wall with hand and throwing the ball against the wall with foot.

GROUP A (BALANCE EXERCISES)

Resisted exercises OTHER

The resistance training protocol include shoulder flexion and extension with 1 kg weight, shoulder pulley with 2 kg weight, arm curls with 1 kg weight, wall push-ups, bridging, hip abduction and adduction against resistance band, knee extensions and flexion in sitting position with resistance applied by contralateral limb, knee adduction and abduction with resistance band, mini squats, strengthening exercise for toes flexor and extensor (22), resisted inversion and eversion and straight leg raise (SLR) with 1 kg ankle weight (10). Every move in each session comprises of 2 sets of 3 reps each and 1 set will be added at 4th and 8th week.

GROUP B (RESISTED EXERCISES)

Eligibility Criteria

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

You may qualify if:

• Patients diagnosed with DNP with score ≥ 2.5 on Michigan neuropathy screening instrument of both genders.
• Age between 40 to 65 years.
• Patients having the minimum history of diabetes is 7 years.
• History of mild to moderate neuropathy . The patients ability to do resistance and aerobic exercises.

You may not qualify if:

• History of taking anti-inflammatory drugs.
• History of recent surgical operations of joints in lower extremities.
• Patients suffering from musculoskeletal disorders such as rheumatoid arthritis and myopathy.
• Patients having any disability, fracture, or dislocation of at least six months before the study.

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

Location

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Muhammad Kashif, PhD-PT

  Riphah International University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The study would be single blinded as assessor of the study would be kept blind of the treatment groups to which patient will be allocated.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 4, 2024
• First Posted: March 12, 2024
• Study Start: February 25, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)