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

Diabetic Neuropathies Clinical Trial

Official title:

Comparative Effects of Proprioceptive Training and Routine Physical Therapy on Balance and Quality Of Life in Individuals With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05968131
• Other study ID #: IRB-UOL-FAHS/997/2021
• Status: Completed
• Phase: N/A
• Start date: October 27, 2021
• Est. completion date: April 27, 2022

Study information

• Verified date: August 2023
• Source: University of Lahore
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 82
• Est. completion date: April 27, 2022
• Est. primary completion date: April 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetic Neuropathies
• Peripheral Nervous System Diseases

Intervention

Other:
• 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.
• 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.

Locations

Country	Name	City	State
Pakistan	District Head Quarter Hospital Layyah.	Layyah	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
University of Lahore

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	The balance score will be monitored at baseline at the recruitment in the study, at 4th week and 8th week of intervention.
Primary	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.	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.