Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy
- Conditions
- Diabetic Neuropathy
- Interventions
- Other: Proprioceptive trainingOther: routine physical therapy
- Registration Number
- NCT05243589
- Lead Sponsor
- Momna Asghar
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
- Patients with pre-diagnosed DM for seven years.
- Male and female patients with type 2 diabetes.
- Patients with ≥2 DPN symptoms.
- Patients scored>2/13 on MNSI questionnaire.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description group A/ routine physical therapy and proprioceptive training routine physical therapy Routine physical therapy and proprioceptive training is performed group A/ routine physical therapy and proprioceptive training Proprioceptive training Routine physical therapy and proprioceptive training is performed Group B/ routine physical therapy routine physical therapy Routine physical therapy
- Primary Outcome Measures
Name Time Method Berg Balance Scale (assessing change in ability to balance at baseline, 4th week and at 6th week. 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. It is a 14-item list with each item consisting of a five-point ordinal scale ranging from 0 to 4.0 denotes inability to complete the item, and 4 the ability to accomplish the task independently (total score range, 0-56; higher = better performance). Scores of less than 45 out of 56 are accepted as indicative of balance disorders in the elderly.
WHO Quality of Life Scale (WHOQOL BREF)( assessing change in quality of life at baseline, 4th and 6th week of intervention. 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. The WHOQOL is a quality of life assessment developed by the WHOQOL Group with fifteen international field centers, simultaneously, in an attempt to develop a quality of life assessment that would be applicable cross-culturally.It contains a total of 26 questions. To provide a broad and comprehensive assessment, one item from each of 24 facets contained in the WHOQOL-100 has been included.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Atofa Rasheed
🇵🇰Lahore, Punjab, Pakistan