Effects of Proprioceptive Training in Addition to Routine Physical Therapy on Balance and Quality of Life in Patients With Diabetic Peripheral Neuropathy

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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Neuropathy
• Intervention / Treatment: Other: Proprioceptive training; Other: routine physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab
    • Lahore, Punjab, Pakistan, 75500
      • Atofa Rasheed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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>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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: group A/ routine physical therapy and proprioceptive training; Routine physical therapy and proprioceptive training is performed	Other: Proprioceptive training; Proprioceptive training included exercises on different floor textures composed of 10 stations of exercises with the objective of stimulating the sole of the foot where participants had to coordinate gait by stepping with alternate feet on markers placed on the ground and the progression was manipulated through modifications of speed and direction. Sequence of materials was 10 cm-thick foam, wood box with beans, two-cm thick mat with a density lower than the foam, wood box with cotton, two-cm thick mat volunteers sat on a bench and trained feet flexors by grasping with the toes a towel put on the floor, Two proprioception balls was used with an eight cm diameter with external projections resting on the floor a box with grains and sandpaper. After that joint Positional Sense Exercises were performed.; Other: routine physical therapy; Routine physical therapy included range of motion exercises for bilateral ankle joints (5 min.), functional balance training (15 min.) involving sit to stand (5 times); standing weight shift (5 times each); functional reach- sideway and anterior for touching targets set by the therapist (5 times each); bipedal heel rise for 20 seconds (5 times); unipedal standing for 15 seconds (5 times each) and unipedal standing with knee bending for 15 second (5 times each). Other exercises was practiced as wobble board training (6 min).
Active Comparator: Group B/ routine physical therapy; Routine physical therapy	Other: routine physical therapy; Routine physical therapy included range of motion exercises for bilateral ankle joints (5 min.), functional balance training (15 min.) involving sit to stand (5 times); standing weight shift (5 times each); functional reach- sideway and anterior for touching targets set by the therapist (5 times each); bipedal heel rise for 20 seconds (5 times); unipedal standing for 15 seconds (5 times each) and unipedal standing with knee bending for 15 second (5 times each). Other exercises was practiced as wobble board training (6 min).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Berg Balance Scale (assessing change in ability to balance at baseline, 4th week and at 6th week.	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.	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.
WHO Quality of Life Scale (WHOQOL BREF)( assessing change in quality of life at baseline, 4th and 6th week of intervention.	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.	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.

Collaborators and Investigators

• Sponsor: Momna Asghar
• Collaborators: University of Lahore
• Investigators: Principal Investigator: Momna Asghar, MSPTN, University of Lahore

Study record dates

Study Major Dates

• Study Start (Actual): February 26, 2021
• Primary Completion (Actual): November 4, 2021
• Study Completion (Actual): December 5, 2021

Study Registration Dates

• First Submitted: February 5, 2022
• First Submitted That Met QC Criteria: February 16, 2022
• First Posted (Actual): February 17, 2022

Study Record Updates

• Last Update Posted (Actual): February 17, 2022
• Last Update Submitted That Met QC Criteria: February 16, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Keywords: Balance; Quality of life; Physical therapy; Neuropathy; Proprioceptive training
• Additional Relevant MeSH Terms: Nervous System Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Neuromuscular Diseases; Peripheral Nervous System Diseases; Diabetic Neuropathies
• Other Study ID Numbers: IRB-UOL-FAHS/823/2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No