- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06303453
Comparative Effects of Balance and Resisted Training in Diabetic Peripheral Neuropathy.
Comparative Effects of Balance and Resisted Training on Pain and Balance In Patients With Diabetic Peripheral Neuropathy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Muhammad Kashif, PhD-PT
- Phone Number: 03333125303
- Email: kashif.shaffi@gmail.com
Study Contact Backup
- Name: Amna Kanwal, MS-NMPT*
- Phone Number: 03064783868
- Email: amnakanwal867@gmail.com
Study Locations
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Punjab
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Lahore, Punjab, Pakistan, 54660
- Recruiting
- Riphah International University
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Contact:
- Muhammad Kashif, PhD-PT
- Phone Number: 03333125303
- Email: kashif.shaffi@gmail.com
-
Contact:
- Muhammad Kashif, PhD-PT
- Phone Number: 03333125303
- Email: Kashif.shafi@gmail.com
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: GROUP A (BALANCE EXERCISES)
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).
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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.
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Experimental: GROUP B (RESISTED EXERCISES)
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).
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Michigan neuropathy screening instrument
Time Frame: 8th week
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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.
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8th week
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De Morton mobility index test
Time Frame: 8th week
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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.
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8th week
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PainDETECT Tool
Time Frame: 8th week
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painDETECT scale to detect diabetic neuropathic pain which includes symptom questioning and also the type, severity and the radiation of pain.
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8th week
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Muhammad Kashif, PhD-PT, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/23/0291
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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