Clinical trial NCT05593133: PNF and Gait Training on Balance and Gait in Diabetic Neueopathy Patients
Official title: Comparative Effects of PNF and Gait Training Exercises on Balance and Gait in Patients With Diabetic Neuropathy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: PNF
DGI
BBS
TAT
MNSI
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2022-10-25
Enrollment: 40
Sex: ALL
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: tinnete scale
timeFrame: 8 weeks
measure: Berg Balance Scale
timeFrame: 8 weeks
measure: Dynamic Gait index
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Central Park Teaching Hospital
state: Punjab
Study officials:
affiliation: Riphah International University
name: Sumera Azam, Mphil
role: PRINCIPAL_INVESTIGATOR
References: