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Comparative Effects of Proprioceptive Training and Routine Physical Therapy on Diabetic Peripheral Neuropathy

Primary Purpose

Diabetic Neuropathies

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Conventional Physical Therapy
Conventional Physical Therapy with Proprioceptive Training Exercises
Sponsored by
University of Lahore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Neuropathies focused on measuring Diabetes, Diabetic Peripheral Neuropathy, Balance, Quality of Life, Proprioceptive Training, Physiotherapy

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Age is between 35- 65 years Both gender (male & female) Diagnosed Type 2 Diabetes with the appearance of peripheral neuropathy from at least six month Michigan Neuropathy Screening Instrument Questionnaire score of 5 or greater. Patient is able to stand on both feet Exclusion Criteria: Foot ulceration/ Infection Amputation Inner ear infection Neurological illness that affects balance Musculoskeletal problems such as vertebral column and limb deformity Patient with any orthotic device

Sites / Locations

  • District Head Quarter Hospital Layyah.

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Physical Therapy

Conventional Physical Therapy with Proprioceptive Training Exercises

Arm Description

Conventional Physical Therapy will consist of application heat pack, ROM exercises, stretching, and strengthening exercises

Conventional Physical Therapy with Proprioceptive Training Exercises

Outcomes

Primary Outcome Measures

Balance Score
Berg Balance Scale (BBS) evaluates functional balance before and after intervention. It is a valid and reliable scale including 14 functional tests, which can quantitatively evaluate balance in community dwelling adults and patients with balance disorders. Berg Balance Scale completion needs 10-20 min. and its score represents the participant's ability to control postural balance. It score ranges from 0 to 56. A total score of 0-20 reflects mobility by wheelchair, 21 to 40 walking with assistance, and a score of 41 to 56 walking independently.
Change in Quality of Life
It is defined by the World Health Organization as individual's perception of their position in life in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards and concerns.33The 36-Item Short Form Health Survey questionnaire (SF-36) is popular instrument for evaluating Health-Related Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). All scales do contribute in different proportions to the scoring of both PCS and MCS measures. It scores range from 0 to 100, with higher scores representing better health status.

Secondary Outcome Measures

Full Information

First Posted
July 21, 2023
Last Updated
August 9, 2023
Sponsor
University of Lahore
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1. Study Identification

Unique Protocol Identification Number
NCT05968131
Brief Title
Comparative Effects of Proprioceptive Training and Routine Physical Therapy on Diabetic Peripheral Neuropathy
Official Title
Comparative Effects of Proprioceptive Training and Routine Physical Therapy on Balance and Quality Of Life in Individuals With Diabetic Peripheral Neuropathy
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
October 27, 2021 (Actual)
Primary Completion Date
April 1, 2022 (Actual)
Study Completion Date
April 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
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
This project will compare the effects of proprioceptive training with routine physical therapy intervention on improving balance and health-related quality of life in individuals with diabetic neuropathy. The subjects who met the inclusion/exclusion criteria will be allocated for controlled and experimental groups. Subjects will be selected from the outpatient clinic of the Department of Physical Therapy. Subjects will be divided randomly into two equal groups. The study will be single-blinded. Subjects will be randomized into two groups Group A & Group B.Baseline data will be collected then collect data at2nd, 4th Week and 8th week.Individuals will be assigned to the intervention group receive proprioceptive training and strengthening interventions guided by a physiotherapist for 8 weeks. Session will begin with a 5 min pre-exercise warm-up of gentle stretches and will be ended with a 5 min cool-down of slow walking. Participant should encourage to perform the exercises for at least four times a week and home-based exercises for once a day.
Detailed Description
This project will compare the effects of proprioceptive training with routine physical therapy intervention on improving balance and health-related quality of life in individuals with diabetic neuropathy. The subjects who met the inclusion/exclusion criteria will be allocated for controlled and experimental groups. Subjects will be selected from the outpatient clinic of the Department of Physical Therapy. Subjects will be divided randomly into two equal groups. The study will be single-blinded. Subjects will be randomized into two groups Group A & Group B.Baseline data will be collected then collect data at2nd, 4th Week, and 8th weeks. FOR CONVENTIONAL PHYSICAL THERAPY GROUPS: The control group will receive only strength training intervention included the following components: Range Of Motion Exercises: movements to the extent possible of the knee (flexion-extension), ankle (Dorsi, plantar flexion), forefoot (inversion-eversion), and toe (flexion-extension). 5 repetitions of each ROM exercise will be done for 2 minutes. Muscle Strengthening Exercises: active movements against resistance (using a Thera band) at the knee (flexion-extension), ankle (dorsiflexion and plantar flexion), forefoot (inversion- eversion), and toe (flexion-extension). Each Strengthening exercise will be performed for 5 minutes with 10 repetitions. FOR INTERVENTIONAL PHYSICAL THERAPY GROUP: The interventional group will receive strengthening intervention as well as proprioceptive training for 32 sessions. ROM and Strengthening exercises will be performed the same as in the control group. Exercises For Proprioceptive Training: Intervention group will practice an additional 24 minutes of proprioceptive training (two minutes rest prior to performing this training). A circuit with different floor textures composed of 6 stations of exercises to stimulate the sole of the foot where the participant had to improve gait by stepping with alternate feet marker placed on the ground and progression will be done by modifying the speed and direction. The material used to build the circuit are in the following order: 10 cm thick foam, a wood box with beans, a 2 cm thick mat with density lower than foam, a wooden box filled with sand, a balance board to train the lateral balance reactions, a wooden box filled with cotton. The duration of this training is 24 minutes; the patient will spend 4 minutes on each station

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
Keywords
Diabetes, Diabetic Peripheral Neuropathy, Balance, Quality of Life, Proprioceptive Training, Physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
The study will be single-blinded. The assessor will be unaware of the treatment given to both groups.
Allocation
Randomized
Enrollment
82 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Physical Therapy
Arm Type
Active Comparator
Arm Description
Conventional Physical Therapy will consist of application heat pack, ROM exercises, stretching, and strengthening exercises
Arm Title
Conventional Physical Therapy with Proprioceptive Training Exercises
Arm Type
Experimental
Arm Description
Conventional Physical Therapy with Proprioceptive Training Exercises
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy
Intervention Description
The control group will receive only strength training intervention included the following components: Range Of Motion Exercises: movements to the extent possible of the knee (flexion-extension), ankle (dorsi-plantar flexion), forefoot (inversion-eversion) and toe (flexion-extension). 5 repetitions of each ROM exercise will be done for 2 minutes. Muscle Strengthening Exercises: active movements against resistance (using a Thera band) at the knee (flexion-extension), ankle (dorsi-plantar flexion), forefoot (inversion- eversion) and toe (flexion-extension). Each Strengthening exercise will be performed for 5 minutes with 10 repetitions.
Intervention Type
Other
Intervention Name(s)
Conventional Physical Therapy with Proprioceptive Training Exercises
Intervention Description
Interventional group will receive strengthening intervention as well as proprioceptive training for 32 sessions. ROM and Strengthening exercise will be performed same as in control group. Exercises For Proprioceptive Training: Intervention group will practice an additional 24 minutes of proprioceptive training (two minutes rest prior to performing this training). A circuit with different floor texture composed of 6 stations of exercises to stimulate the sole of foot where participant had to improve gait by stepping with alternate feet marker placed on ground and progression will be done by modify the speed and direction. Material used to build the circuit are in following order: 10 cm thick foam, a wood box with beans, a 2 cm thick mat with density lower than foam, a wooden box filled with sand, balance board to train the lateral balance reactions, a wooden box filled with cotton. Duration of this training is 24 minutes; patient will spend 4 minutes on each station.
Primary Outcome Measure Information:
Title
Balance Score
Description
Berg Balance Scale (BBS) evaluates functional balance before and after intervention. It is a valid and reliable scale including 14 functional tests, which can quantitatively evaluate balance in community dwelling adults and patients with balance disorders. Berg Balance Scale completion needs 10-20 min. and its score represents the participant's ability to control postural balance. It score ranges from 0 to 56. A total score of 0-20 reflects mobility by wheelchair, 21 to 40 walking with assistance, and a score of 41 to 56 walking independently.
Time Frame
The balance score will be monitored at baseline at the recruitment in the study, at 4th week and 8th week of intervention.
Title
Change in Quality of Life
Description
It is defined by the World Health Organization as individual's perception of their position in life in the context of the culture and value systems in which they live, and in relation to their goals, expectations, standards and concerns.33The 36-Item Short Form Health Survey questionnaire (SF-36) is popular instrument for evaluating Health-Related Quality of Life. The SF-36 measures eight scales: physical functioning (PF), role physical (RP), bodily pain (BP), general health (GH), vitality (VT), social functioning (SF), role emotional (RE), and mental health (MH). Component analyses showed that there are two distinct concepts measured by the SF-36: a physical dimension, represented by the Physical Component Summary (PCS), and a mental dimension, represented by the Mental Component Summary (MCS). All scales do contribute in different proportions to the scoring of both PCS and MCS measures. It scores range from 0 to 100, with higher scores representing better health status.
Time Frame
Quality of life will be measured at the baseline, and any change in quality of life will be measured at 4th week and 8th week of intervention.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age is between 35- 65 years Both gender (male & female) Diagnosed Type 2 Diabetes with the appearance of peripheral neuropathy from at least six month Michigan Neuropathy Screening Instrument Questionnaire score of 5 or greater. Patient is able to stand on both feet Exclusion Criteria: Foot ulceration/ Infection Amputation Inner ear infection Neurological illness that affects balance Musculoskeletal problems such as vertebral column and limb deformity Patient with any orthotic device
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sidra Naz, MS
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
District Head Quarter Hospital Layyah.
City
Layyah
State/Province
Punjab
ZIP/Postal Code
31200
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32110590
Citation
Sendi RA, Mahrus AM, Saeed RM, Mohammed MA, Al-Dubai SAR. Diabetic peripheral neuropathy among Saudi diabetic patients: A multicenter cross-sectional study at primary health care setting. J Family Med Prim Care. 2020 Jan 28;9(1):197-201. doi: 10.4103/jfmpc.jfmpc_927_19. eCollection 2020 Jan.
Results Reference
background
PubMed Identifier
33193090
Citation
Riandini T, Khoo EYH, Tai BC, Tavintharan S, Phua MSLA, Chandran K, Hwang SW, Venkataraman K. Fall Risk and Balance Confidence in Patients With Diabetic Peripheral Neuropathy: An Observational Study. Front Endocrinol (Lausanne). 2020 Oct 23;11:573804. doi: 10.3389/fendo.2020.573804. eCollection 2020.
Results Reference
background
PubMed Identifier
28334605
Citation
Feldman EL, Nave KA, Jensen TS, Bennett DLH. New Horizons in Diabetic Neuropathy: Mechanisms, Bioenergetics, and Pain. Neuron. 2017 Mar 22;93(6):1296-1313. doi: 10.1016/j.neuron.2017.02.005.
Results Reference
background

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Comparative Effects of Proprioceptive Training and Routine Physical Therapy on Diabetic Peripheral Neuropathy

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