Additional Effects of Sensory Integration Along With Focused Regimen Exercises on Kinaesthesia & Proprioception in Diabetic Peripheral Neuropathy.

NCT07332364 | Completed

• 1 other identifier: FUI/CTR/2025/15
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate Additional Effects of sensory integration along with focused regimen exercises on kinaesthesia \& proprioception in Diabetic peripheral neuropathy Peripheral neuropathy a Condition occur when the nerves outside the brain and spinal cord are damaged. It affects the upper and lower extremity. The estimated prevalence of peripheral neuropathy in patients with diabetes in Pakistan is around 43%. The condition is more common in those who have poorly controlled diabetes. Signs and symptoms include Numbness, tingling, Pain, which may be burning, stabbing or shooting, unusual touch-based sensations (dysesthesia), Muscle weakness, Total or partial loss of sensation in feet, like not feeling pain from foot injuries, loss of position and movement sense. Kinaesthesia and proprioception are defined as awareness of the position and movement of the body parts by sensory organs (proprioceptors) in the muscles and joints. Uncoordinated movement, clumsiness, poor postural control are common symptoms. Multiple treatment options are available for training kinaesthesia and proprioception impairments in peripheral neuropathy including use of electrotherapeutic agents, proprioception exercises, sensory integration, and focused regimen exercises. Current study will be RCT on 40 participants recruited on the basis of inclusion criteria which are Diagnosed as Type 2 Diabetic peripheral neuropathy (DPN) by physician in the age group of 45-65 Years in Both genders with type 2 Diabetes. Patients with moderate neuropathy according to Michigan nephropathy screening tool and having the ability to walk with or without assistance. Participants will be randomly and equally divided into two groups; group A will be receiving focused regimen exercises and group B will be receiving both sensory integration exercises along with focused regimen exercises. The treatment will be given for 45min, 3 days a week for total of 8 weeks. The assessment will be conducted at baseline by (Michigan neuropathy screening tool, Brief kinaesthesia test (BKT), Modified Clinical Test of Sensory Interaction for balance (mCTSIB), Norfolk quality of life for diabetic neuropathy), and final assessment will be conducted after 8 weeks of treatment.

Conditions

Diabetic Neuropathy; Proprioception

Keywords

physical therapy; diabetic neuropathy; kinesthesia; proprioception; exercises

Outcome Measures

Primary Outcomes (3)

• Kinesthesia and Proprioception

  The Brief kinaesthesia Test (BKT) is used to assess kinaesthesia and proprioception in the ankle by evaluating joint position sense (JPS) and movement detection (Threshold to Detect Passive Motion - TTDPM). Scoring Interpretation of JPS: 0-2 error = Good proprioception 2.1-4 error= mild impairment 4.1-7 error = Moderate impairment \>7 error = Poor proprioception Movement Detection Test (Threshold to Detect Passive Motion - TTDPM) Determine the smallest movement the participant can detect. Scoring Interpretation of TTDPM: 0-2 threshold = Excellent proprioception 2.1-4 threshold = Mild impairment 4.1-6 threshold= moderate impairment \>6.0 threshold = Poor proprioception

  8 weeks

• Quality of Life of Diabetic Peripheral Neuropathy Patients

  The Norfolk QoL-DN is a validated questionnaire used to assess the impact of diabetic neuropathy (DN) on a patient's quality of life. It covers sensory, autonomic, motor, and psychosocial aspects of neuropathy. Minimum score = 0 (No neuropathy) Maximum score = 140 (Severe neuropathy impact) Interpretation Total Score Range Severity 0-20 No neuropathy 21-40 Mild neuropathy 41-70 Moderate neuropathy \>70 Severe neuropathy A higher score indicates worse neuropathic impact.

  8 weeks

• Sensory Balance

  The Modified Clinical Test of Sensory Interaction in Balance (mCTSIB) evaluates postural control by testing balance under different sensory conditions. It is used to assess impairments in vestibular, somatosensory, and visual systems, making it valuable for diagnosing balance disorders. Maximum Score = 120 seconds (if all conditions are completed successfully). Minimum Score = 0 seconds (if unable to balance in any condition). Scoring Interpretation Total Score (out of 120 sec) Balance Impairment Level \>110 sec Normal Balance 90-109 sec Mild Impairment 60-89 sec Moderate Impairment \<60 sec Severe Impairment

  8 weeks

Study Arms (2)

sensory integration exercises along with focused regimen exercise

EXPERIMENTAL

8-week progressive balance, strength, and sensory stimulation program, performed three sessions per week. Weeks 1-2 focused on sensory activation and basic strengthening, including textured ball rolling and brushing of the feet, ankle circles, toe scrunches, double-leg calf raises, resistance-band ankle exercises, weight-shifting on a foam pad, and 10 minutes of TENS at comfortable intensity. Weeks 3-4 progressed to single-leg calf raises, tandem walking, balance board training, and reduced TENS duration (8 minutes). Weeks 5-6 emphasized dynamic balance and functional strength through single-leg balance with ball toss, barefoot walking on uneven surfaces, squats, multidirectional stepping, and 6 minutes of TENS. Weeks 7-8 advanced balance challenges with obstacle walking, wobble board training with minimal support, barefoot balance with ball toss on uneven ground, weighted calf raises, single-leg stance, and eyes-closed balance exercises to enhance proprioception and postural control.

Procedure: Sensory integration and focused regimen

focused regimen exercises

ACTIVE COMPARATOR

The exercise program was delivered over 8 weeks, with participants completing three sessions per week and progressing in difficulty. During weeks 1-2, the focus was on basic strengthening and ankle control through double-leg calf raises and resistance-band ankle exercises, including dorsiflexion, plantarflexion, inversion, and eversion to improve ankle mobility and muscle activation. Weeks 3-4 introduced unilateral strengthening and functional balance tasks, such as single-leg calf raises, step-ups using a low platform, and balance board training to enhance postural stability. In weeks 5-6, the program emphasized functional lower-limb strength and dynamic balance using double-leg squats and multidirectional stepping exercises. During weeks 7-8, the intensity was increased with weighted calf raises, prolonged single-leg stance exercises, and eyes-closed balance training to challenge proprioception and postural control.

Procedure: Focused Regimen Exercise

Interventions

Sensory integration and focused regimen PROCEDURE

3 sessions/week 1-2 weeks : textured ball and brush on feet. (3-5 min/foot). Ankle circles, toe scrunches.10 reps x 2 sets, Tens 10min, 2 sets calf raises (10 reps). resistance band (10 reps x 2 sets). 3-4 weeks: Shift weight side-to-side and forward-backward on foam pad (10 reps x 2 sets). calf raises, progressing to single-leg calf raises 10 reps x 2 sets. Step-ups: Step up and down 10 reps x 2 sets. Standing on board 30 sec. Open. 5-6 weeks: Tandem walking. Tens 8min. Balance on one leg while catching a ball (20-30 sec). barefoot walking (grass, gravel).Tens 6min. Double-leg squats10 reps x 1 set. side-to-side and forward-backward stepping 10 reps x 2 sets. 7-8 weeks: Walk over \& around obstacles. Balance wobble board for 30 sec-2 reps. Balance barefoot on uneven terrain while catching a ball. Weighted calf raises 10 reps x 3 sets. Standing on firm surface for 30 sec. Eyes close, Single-leg stance 10 reps x 3 sets

sensory integration exercises along with focused regimen exercise

Focused Regimen Exercise PROCEDURE

3 sessions/week 1-2 weeks Perform 2 sets of calf raises (10 reps). Use a resistance band (green colour) 10 reps x 2 sets. 3-4 weeks: calf raises, progressing to single-leg calf raises. 10 reps x 2 sets Step-ups: Step up and down on a low step 10 reps x 2 sets. Standing on board for 30 sec. Open. 5-6 weeks :Double-leg squats10 reps x 1 set. Perform side-to-side and forward-backward stepping 10 reps x 2 sets Weighted . 7-8 weeks: calf raises 10 reps x 3 sets. Standing on firm surface for 30 sec. Eyes close, Single-leg stance on firm ground10 reps x 3 sets

focused regimen exercises

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants Diagnosed as Type 2 DPN by physician.
• Age between 45-65 Years.
• Both genders males and females.
• Patient with moderate neuropathy according to Michigan neuropathy screening tool.
• Ability to walk with or without assistance

You may not qualify if:

• Unstable Cardiovascular diseases. (Myocardial infarction, Heart failure, Coronary artery disease, Arrythmias)
• Severe visual disorders. (Cataracts, Glaucoma, Macular degeneration)
• Severe musculoskeletal problems of lower limb (Fractures).
• Any metal implant. (presence of pacemaker, artificial joints or screws in lower extremity).
• Unable to follow basic instructions

Sponsors & Collaborators

• Foundation University Islamabad: lead

Study Sites (1)

Foundation University College of Physical Therapy

Islamabad, 44000, Pakistan

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Motor Activity

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Diabetes Mellitus; Endocrine System Diseases; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2025
• First Posted: January 12, 2026
• Study Start: September 15, 2025
• Primary Completion: October 26, 2025
• Study Completion: December 20, 2025
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

PA (1)