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

Primary Purpose

Diabetic Neuropathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Proprioceptive training
routine physical therapy
Sponsored by
Momna Asghar
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathy focused on measuring Neuropathy, Proprioceptive training, Balance, Quality of life, Physical therapy

Eligibility Criteria

50 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Atofa Rasheed

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group A/ routine physical therapy and proprioceptive training

Group B/ routine physical therapy

Arm Description

Routine physical therapy and proprioceptive training is performed

Routine physical therapy

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
February 5, 2022
Last Updated
February 16, 2022
Sponsor
Momna Asghar
Collaborators
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05243589
Brief Title
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

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
February 26, 2021 (Actual)
Primary Completion Date
November 4, 2021 (Actual)
Study Completion Date
December 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Momna Asghar
Collaborators
University of Lahore

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathy
Keywords
Neuropathy, Proprioceptive training, Balance, Quality of life, Physical therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
single blinded
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A/ routine physical therapy and proprioceptive training
Arm Type
Experimental
Arm Description
Routine physical therapy and proprioceptive training is performed
Arm Title
Group B/ routine physical therapy
Arm Type
Active Comparator
Arm Description
Routine physical therapy
Intervention Type
Other
Intervention Name(s)
Proprioceptive training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
routine physical therapy
Intervention Description
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).
Primary Outcome Measure Information:
Title
Berg Balance Scale (assessing change in ability to balance at baseline, 4th week and at 6th week.
Description
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.
Time Frame
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.
Title
WHO Quality of Life Scale (WHOQOL BREF)( assessing change in quality of life at baseline, 4th and 6th week of intervention.
Description
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.
Time Frame
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.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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>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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Momna Asghar, MSPTN
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Atofa Rasheed
City
Lahore
State/Province
Punjab
ZIP/Postal Code
75500
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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