Skip to main content
OpenTrials
Completed

NCT Number: NCT05593133

PNF and Gait Training on Balance and Gait in Diabetic Neueopathy Patients

To determine the effects of PNF and Gait Training Exercises on Balance and Gait in diabetic neuropathy patients . 40 patients will be explained in detail about the study procedure. Informed consent will be taken. Patients will be divided in two groups each consisting of 20 people.

Subjects will be evaluated using the Michigan Neuropathy Screening Questionnaire (screening tool) . One group will be tested by PNF techniques and the second group will be tested by Gait Training exercises.

Balance will be assessed by Berg Balance scale (BBS) and Tinetti scale before, during and after the study to assess risk of fall and injury. Gait will be assessed by Dynamic Gait index in the same manner. All patients will be followed up with the therapist regularly twice a week for 30 minutes session each for a duration of 8 weeks.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Diabetic Neuropathies Diabetes Complications Diabetes Mellitus Endocrine System Diseases Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

45 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Central Park Teaching Hospital

Lahore, Punjab Province, 042, Pakistan

About this study

Objective To determine the effects of PNF and Gait Training Exercises on Balance and Gait in diabetic neuropathy patients Hypothesis Null hypothesis : There is no difference between PNF and Gait Training Exercises.

Alternative hypothesis : There is difference between PNF and Gait Training Exercises

Methodology (Design, sample size, sampling technique, inclusion and exclusion criteria and tool) Study design: This study is Randomized Clinical Trial Sample size: Sample size will be 40 (Two groups of 20 each) Assumed standard deviation=6.5 Confidence interval= 0.95 Desired precision=2 Calculated by epitool. Sampling technique: Convenient sampling will be used to collect data. Study design setting: Data will be conducted from Hospital wards and Outpatient departments

Inclusion criteria

Both male and female in the age group Patients suffering from Diabetes Mellitus (Type 1, Type 2), suffering From effects of diabetic neuropathy such as Gait instability, imbalance, numbness, tingling, Paresthesia in lower limbs for a duration of at least three months.

  • HbA1c more than 7 from 6 months.
  • Score higher than 7 out of 15 in the Michigan Neuropathy questionnaire scale and Examination score higher than 2.5.

Exclusion criteria

  • Patients suffering from significant CNS dysfunctions.
  • Musculoskeletal deformities
  • Vestibular dysfunction
  • Internal ear infections
  • Complete sensory loss
  • Hypoglycemia
  • Lower extremity arthritis or pain that limits standing or weight bearing. Data collection procedure All 40 patients will be explained in detail about the study procedure. Informed consent will be taken. Patients will be divided in two groups each consisting of 20 people.

Subjects will be evaluated using the Michigan Neuropathy Screening Questionnaire (screening tool) . One group will be tested by PNF techniques and the second group will be tested by Gait Training exercises.

PNF techniques will comprise of Warm up, Rhythmic stabilization, Hold Relax, Contract Relax and light exercises and performed on three muscle groups ( Hamstring, Quad and Calf).

Gait Training exercises will comprise of One Foot Balancing, Leg raises, Heel raises, Tight-rope Walking.

Balance will be assessed by Berg Balance scale (BBS) and Tinetti scale before, during and after the study to assess risk of fall and injury. Gait will be assessed by Dynamic Gait index in the same manner. All patients will be followed up with the therapist regularly twice a week for 30 minutes session each for a duration of 8 weeks.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

Both male and female in the age group 40-65 • Patients suffering from Diabetes Mellitus (Type 1, Type 2), suffering From effects of diabetic neuropathy such as Gait instability, imbalance, numbness, tingling, Paresthesia in lower limbs for a duration of at least three months.

  • HbA1c more than 7 from 6 months.
  • Score higher than 7 out of 15 in the Michigan Neuropathy questionnaire scale and Examination score higher than 2.5.

Exclusion criteria

  • Patients suffering from significant CNS dysfunctions.
  • Musculoskeletal deformities
  • Vestibular dysfunction
  • Internal ear infections
  • Complete sensory loss

Treatment and study plan

PNF Exercises

Other

PNF techniques will comprise of Warm up, Rhythmic stabilization, Hold Relax, Contract Relax and light exercises and performed on three muscle groups ( Hamstring, Quad and Calf).

20 participants will be followed up with the therapist regularly twice a week for 30 minutes session each for a duration of 8 weeks.

Gait training exercises

Other

gait Training exercises comprised of one foot balancing, leg raises, heel raises, tight-rope walking. 20 participants will be followed up with the therapist regularly twice a week for 30 minutes session each for a duration of 8 weeks.

Primary outcomes

  1. tinnete scale

    Time frame: 8 weeks

    The test requires a hard armless chair, a stopwatch and also, a 15 feet even and uniform walkway. It has 2 sections: one assesses balance abilities in a chair and also in standing; the other assesses dynamic balance during gait on a 15 feet even walkway.Next, the patient will have to walk a few meters at a normal speed, followed by turning and walking back at a "fast but safe" speed. The patient will then sit back down. As well as in the first part of the test, there are some points the evaluator has to look at. These are the length and height of the steps, the symmetry and continuity of the steps and straightness of the trunk.

    During this test, the patient can use any assistive devices (walking stick, crutches, zimmer frame) they would normally use

  2. Berg Balance Scale

    Time frame: 8 weeks

    Document each task and/or give instructions as written. When scoring, please record the lowest response category that applies for each item.

    In most items, the subject is asked to maintain a given position for a specific time. Progressively more points are deducted if:

    the time or distance requirements are not met the subject's performance warrants supervision the subject touches an external support or receives assistance from the examiner The subject should understand that they must maintain their balance while attempting the tasks. The choices of which leg to stand on or how far to reach are left to the subject. Poor judgment will adversely influence the performance and the scoring.

    Equipment required for testing is a stopwatch or watch with a second hand, and a ruler or other indicator of 2, 5, and 10 inches. Chairs used during testing should be a reasonable height. Either a step or a stool of average step height may be used for item.

  3. Dynamic Gait index

    Time frame: 8 weeks

    8 functional walking tests are performed by the subject and marked out of three according to the lowest category which applies. 24 is the total individual score possible. Scores of 19 or less have been related to increase incidence of falls.

    Equipment needed

    Box (Shoebox), Cones (2), Stairs, 20' walkway, 15" wide

    Completion Time

    15 minutes

Sponsors and collaborators

Lead sponsor

Riphah International University

Other

Registry information

Official study title

Comparative Effects of PNF and Gait Training Exercises on Balance and Gait in Patients With Diabetic Neuropathy

Important dates

Study start
2021
Primary completion
2021
Study completion
2022
First posted
Oct 25, 2022
Registry last updated
Oct 25, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.