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

NCT05243589 | Completed DMC

• 1 other identifier: IRB-UOL-FAHS/823/2021
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetic Neuropathy

Keywords

Neuropathy; Proprioceptive training; Balance; Quality of life; Physical therapy

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

group A/ routine physical therapy and proprioceptive training

EXPERIMENTAL

Routine physical therapy and proprioceptive training is performed

Other: Proprioceptive training; Other: routine physical therapy

Group B/ routine physical therapy

ACTIVE COMPARATOR

Routine physical therapy

Other: routine physical therapy

Interventions

Proprioceptive training OTHER

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.

group A/ routine physical therapy and proprioceptive training

routine physical therapy OTHER

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).

Group B/ routine physical therapy; group A/ routine physical therapy and proprioceptive training

Eligibility Criteria

• Age: 50 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Momna Asghar: lead
• University of Lahore: collaborator

Study Sites (1)

Atofa Rasheed

Lahore, Punjab Province, 75500, Pakistan

Location

MeSH Terms

Conditions

Diabetic Neuropathies

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases

Study Officials

• Momna Asghar, MSPTN

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: single blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: February 5, 2022
• First Posted: February 17, 2022
• Study Start: February 26, 2021
• Primary Completion: November 4, 2021
• Study Completion: December 5, 2021
• Last Updated: February 17, 2022

Record last verified: 2022-02

Locations

PA (1)