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NCT Number: NCT06303453

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

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.

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Key information

Conditions

Diabetic Peripheral Neuropathy Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

40 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Riphah International University

Lahore, Punjab Province, 54660, Pakistan

About this study

This randomized clinical trial will be conducted at Mumtaz Bakhtawar Hospital in 7 months after the approval of synopsis. The sample size for this trial will be 58 patients with DPN. Participants those meet inclusion criteria will be randomly allocated into two groups using online randomization tool, 29 participants will be assigned to Group A which will receive Balance training exercises for 35 minutes and Group B will receive Resistance Training exercises for 45 minutes. Each participant will receive intervention for 3 alternate days per week for 8 weeks.

The Michigan neuropathy screening instrument will be used for the assessment of DPN symptoms scores at baseline. Balance will be evaluated using the De Morton mobility index (DEMMI) test, while painDIRECT tool will be utilized to measure pain. The data will be entered and analyzed using SPSS version 24 for windows software.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Michigan neuropathy screening instrument

    Time frame: 8th week

    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.

  2. De Morton mobility index test

    Time frame: 8th week

    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.

  3. PainDETECT Tool

    Time frame: 8th week

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

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of Balance and Resisted Training on Pain and Balance In Patients With Diabetic Peripheral Neuropathy.

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 12, 2024
Registry last updated
Oct 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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