Clinical trial NCT05243589: Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy
Official title: Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathy
Keywords: Neuropathy
Proprioceptive training
Balance
Quality of life
Physical therapy
Lead sponsor: University of Lahore
Sponsor class: OTHER
Collaborators: name: University of Lahore
First posted: 2022-02-17
Enrollment: 64
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Objective of the study is to find out the effects of Proprioceptive training in addition to routine physical therapy on balance and quality of life in patients with Diabetic neuropathy.

Alternate Hypothesis:

There will be significant difference in effects of Proprioceptive training in addition to routine physical therapy on balance and Quality of life in patients with Diabetic neuropathy.

Detailed description: It was a parallel designed single blinded randomized controlled trial conducted in the Green Poly Clinic Bahria town, Lahore, Pakistan using non probability convenient sampling. patients who met eligibility criteria was informed about the aim of study. consent form were signed by all participants.After baseline assessment ,participants were randomly assigned in two groups.(ratio 1:1) The calcualted sample size was 27 in each group. i.e. 54 ( 27 in each group). After adding 20% drop out the final size will become, 64( 32 in each group) using 95% level of significance and 80% power of study.

Eligibility criteria: Inclusion Criteria:

* Patients with pre-diagnosed DM for seven years.
* Male and female patients with type 2 diabetes.
* Patients with ≥2 DPN symptoms.
* Patients scored\&gt;2/13 on MNSI questionnaire.

Exclusion Criteria:

* Participants with Foot ulcers, Orthopedic or surgical problem in a lower limb, other neurological impairment and Major vascular complication,
* Severe vestibular dysfunction
* Participants with Severe retinopathy and Severe nephropathy,
* Inability to walk independently with or without an assistive device,
* Receiving any structured supervised physiotherapy intervention.

Primary outcomes:
measure: Berg Balance Scale (assessing change in ability to balance at baseline, 4th week and at 6th week.
timeFrame: It was checked before the intervention started (after recruitment of patient) and then checked at the 4th week and then at the end of 6th weeks.
measure: WHO Quality of Life Scale (WHOQOL BREF)( assessing change in quality of life at baseline, 4th and 6th week of intervention.
timeFrame: It was checked before the intervention started (after recruitment of patient) and then checked at the 4th week and then at the end of 6th weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Atofa Rasheed
state: Punjab
Study officials:
affiliation: University of Lahore
name: Momna Asghar, MSPTN
role: PRINCIPAL_INVESTIGATOR
References: