Clinical trial NCT05968131: 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
Overall status: COMPLETED
Phase: NA
Conditions: Diabetic Neuropathies
Keywords: Diabetes
Diabetic Peripheral Neuropathy
Balance
Quality of Life
Proprioceptive Training
Physiotherapy
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2023-08-01
Enrollment: 82
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Eligibility criteria: 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

Primary outcomes:
measure: Balance Score
timeFrame: The balance score will be monitored at baseline at the recruitment in the study, at 4th week and 8th week of intervention.
measure: Change in Quality of Life
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Layyah
country: Pakistan
facility: District Head Quarter Hospital Layyah.
state: Punjab
Study officials:
affiliation: University of Lahore
name: Sidra Naz, MS
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.