NCT07575126

Brief Summary

This study seeks to compare these two interventions to better understand their impact on key health outcomes in patients affected by diabetic neuropathy, providing valuable insights for clinicians and healthcare providers managing this challenging condition

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
4mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2026

Completed
2 months until next milestone

First Posted

Study publicly available on registry

May 8, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

May 15, 2026

Expected
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2026

15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

May 8, 2026

Status Verified

May 1, 2026

Enrollment Period

3 months

First QC Date

February 23, 2026

Last Update Submit

May 4, 2026

Conditions

Outcome Measures

Primary Outcomes (5)

  • Agility T-Test

    The Agility T-Test is a performance-based assessment that measures an individual's agility and ability to change direction quickly. It involves a sequence where the participant runs to a designated point, makes sharp turns around markers in a T-shaped layout, and returns to the starting position.

    12th week

  • Berg Balance Scale

    is the gold standard test for static and dynamic balance abilities. The BBS is used to measure ability to maintain balance while doing functional task search as reach, standing position and transferences. It is a valid instrument used for the evaluation of effectiveness of interventions with quantitative description of function in clinical practice as well as research. It consists of 14 items including simple balance tasks from everyday life.

    12th week

  • Functional Reach Test

    FRT is a single item test for dynamic balance and acts as a quick screen for balance problems in older adults. The distance between the lengths of an outstretched arm in a maximal forward reach, while maintaining a fixed base of support is measured. A score of 6 inches or less indicates a significant increased risk for falls. A score between 6-10 inches indicates a moderate risk for falls. the Functional Reach Test (FRT) demonstrates an ICC of approximately 0.85 to 0.94

    12th week

  • Gait Speed Test

    The Gait Speed Test measures the time it takes for an individual to walk a specific distance, usually 10 meters, at their usual pace. It has demonstrated strong validity and reliability, with an Intra class Correlation Coefficient (ICC) often exceeding 0.90

    12th week

  • 10-Meter Walk Test

    The 10-Meter Walk Test involves timing a participant as they walk a distance of 10 meters at their comfortable pace. It assesses gait speed, which is an important indicator of mobility and overall functional ability.

    12th week

Study Arms (2)

Qigong Balance

EXPERIMENTAL
Other: Qigong Balance

Otago Balance

ACTIVE COMPARATOR
Other: Otago Balance

Interventions

Quigong Balance Exercises 3 times per week for 60 minutes per session Open the Flow: Focus on fluid arm movements to enhance relaxation and improve circulation. Shaking Exercise: A full-body shake to release tension and promote energy flow. Lifting the Ball: Alternating arm movements simulating lifting a ball to improve upper body strength and coordination. Playing with Water: Slow, flowing movements that enhance balance and mindfulness. Weight Shifting and Balance Exercises: Stand with feet hip-width apart, shifting weight slowly from one leg to the other, holding each position for 10-15 seconds to engage stabilizing muscles in the legs and improve proprioception. Leg Lifts and Extensions: Perform controlled leg lifts (front, side, and back) to strengthen the quadriceps, hamstrings, and hip abductors.

Qigong Balance

Otago (Strengthening) Balance: Sit-to-stand exercises: to improve leg strength. Heel raises: to enhance calf strength. Toe stands: for improving foot stability. Balance Training: Single-leg stands: to enhance balance. Tandem walking: along a straight line. Side leg raises: to strengthen hip muscles 3 times per week for 60 minutes per session

Otago Balance

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Physician-diagnosed type 2 diabetes without gender bias, with peripheral neuropathy (defined by Michigan Neuropathy Screening Instrument questionnaire score of 5 or greater)
  • Type 2 diabetic peripheral neuropathy patients
  • The ability to walk independently for 10 m
  • Having score between 46 to 52 (out of a total of 56 points) on the BBS

You may not qualify if:

  • Fracture of the lower limb within the 6 months before the study (15)
  • Diabetic ulcer, infection or partial amputation in feet (15)
  • Disease or functional impairment of auditory, vestibular system (16)
  • Any other medical conditions that would confound assessment of neuropathy such as malignancy, other neurological or orthopedic impairments (such as stroke, poliomyelitis, rheumatoid arthritis, prosthesis, or severe osteoarthritis), major vascular complications (venous or arterial ulcers), severe retinopathy, or severe nephropathy that causes edema or needs hemodialysis (17)
  • Dementia or inability to give consistent information (18)
  • History of surgical procedure at the knee, ankle, or hip or indication of surgery throughout the intervention period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DHQ Gujranwala

Guiranwala, Punjab Province, 54500, Pakistan

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Javeria Ghazal, MS

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2026

First Posted

May 8, 2026

Study Start (Estimated)

May 15, 2026

Primary Completion (Estimated)

August 15, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

May 8, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations