NCT06240910

Brief Summary

Diabetes is a group of metabolic diseases, characterized by hyperglycemia resulting from defects in insulin secretion, actionor both. The chronic hyperglycemia of diabetes is associated with long-term damage, dysfunction, and failure of differentorgans, especially the eyes, kidneys, nerves, heart, and blood vessels. In long standing cases of both diabetes type 1 and 2, about 60 % individuals had diabetic neuropathy. Patients suffering from diabetes are more prone to fall, possibly due to balance issues and sensory ataxia.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 17, 2023

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 5, 2024

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 12, 2024

Completed
Last Updated

February 5, 2024

Status Verified

January 1, 2024

Enrollment Period

7 months

First QC Date

January 28, 2024

Last Update Submit

January 28, 2024

Conditions

Diabetic Neuropathies

Keywords

Aerobic exercise trainingBalance and fallDiabetic neuropathyNeural mobilization

Outcome Measures

Primary Outcomes (1)

  • Berge balance scale

    The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks.

    6 weeks

Secondary Outcomes (1)

  • Functional reach test

    6 weeks

Other Outcomes (3)

  • Morse scale

    6 weeks

  • Romberg test

    6 weeks

  • Michigan neuropathy screening instrument questionnaire

    6 weeks

Study Arms (2)

Neurodynamics

EXPERIMENTAL

Neuro dynamics involving Stretching and gliding of the Sciatic nerve (performing each exercise for 30 s at a slow and comfortable pace of 1 repetition per \~3-4 s. The participants rested for 60 s between each exercise. The total duration of the interventions was approximately 10 min.).The whole treatment session on a single day will be of 40-60 minutes of duration (involving both aerobic exercise + neurodynamics) 3. times a week for 6 weeks according to the American diabetes association, accumulating a minimum of 150 minutes/week.

Other: Neurodynamics

Aerobic training

EXPERIMENTAL

Aerobic exercise will involve warm-up by stretching and flexibility exercises for 5 minutes, Treadmill walking for 6 minutes, and Stationary bicycle for 6 minutes

Other: Aerobic training

Interventions

NeurodynamicsOTHER

Neuro dynamics involving Stretching and gliding of the Sciatic nerve (performing each exercise for 30 s at a slow and comfortable pace of 1 repetition per \~3-4 s. The participants rested for 60 s between each exercise.

Neurodynamics
Aerobic trainingOTHER

Aerobic exercise will involve warm-up by stretching and flexibility exercises for 5 minutes, Treadmill walking for 6 minutes, and Stationary bicycle for 6 minutes

Aerobic training

Eligibility Criteria

Age45 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ranged between 45-67 years.
  • Both male and female genders
  • DM for the past 7 years.
  • Scored \>2/13 on Michigan neuropathy screening instrument (MNSI) questionnaire including at least two DPN symptoms.

You may not qualify if:

  • fracture(s) in the lower limb.
  • Any participant who suffered from foot ulcers.
  • Unstable heart disease, co- Morbid conditions limiting exercise
  • inability of subjects to understand and/or co-operate during quantitative sensory testing or manual/nerve mobility testing and/or treatment.
  • Any level of physical activity i.e 150 minutes/week
  • Receiving any structured supervised physiotherapy interventions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Ripha international university

Lahore, Punjab Province, 5433, Pakistan

RECRUITING

Riphah international university

Lahore, Punjab Province, 5433, Pakistan

RECRUITING

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • Muhammad Asrar Yousaf

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Muhammad Usman, MSPT(NM)

CONTACT

03123381314usmanikram993@gmail.com

Muhammad Aqeel, MSPT(NM)

CONTACT

03037862835ilyassaqeel@gmail.com

Study Design

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

Study Record Dates

First Submitted

January 28, 2024

First Posted

February 5, 2024

Study Start

July 17, 2023

Primary Completion

February 12, 2024

Study Completion

February 12, 2024

Last Updated

February 5, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

PA(2)