Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-25 @ 2:45 AM
NCT ID:
NCT05593133
Brief Summary:
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.
Detailed Description:
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.
Study:
NCT05593133
Study Brief:
Protocol Section:
NCT05593133