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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

82 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-27

Study Completion Date

2022-04-27

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Diabetic Neuropathies

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

The study will be single-blinded. The assessor will be unaware of the treatment given to both groups.

Study Groups

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Conventional Physical Therapy

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

Group Type ACTIVE_COMPARATOR

Conventional Physical Therapy

Intervention Type OTHER

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.

Conventional Physical Therapy with Proprioceptive Training Exercises

Group Type EXPERIMENTAL

Conventional Physical Therapy

Intervention Type OTHER

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.

Conventional Physical Therapy with Proprioceptive Training Exercises

Intervention Type OTHER

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.

Interventions

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Conventional Physical Therapy

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

Conventional Physical Therapy with Proprioceptive Training Exercises

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Age is between 35- 65 years
2. Both gender (male \& female)
3. Diagnosed Type 2 Diabetes with the appearance of peripheral neuropathy from at least six month
4. Michigan Neuropathy Screening Instrument Questionnaire score of 5 or greater.
5. Patient is able to stand on both feet

Exclusion Criteria

1. Foot ulceration/ Infection
2. Amputation
3. Inner ear infection
4. Neurological illness that affects balance
5. Musculoskeletal problems such as vertebral column and limb deformity
6. Patient with any orthotic device

Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No