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CTRI Number  CTRI/2026/02/103570 [Registered on: 10/02/2026] Trial Registered Prospectively
Last Modified On: 09/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effectiveness of Nerve Mobilization Improving the Strength and Sensation in Leg and Feet in People with Diabetes 
Scientific Title of Study   Effect of Manual Neurodynamic Techniques on Motor and Sensory Recovery in Tibial, Peroneal and Sural Neuropathies Among Patients with Type 2 Diabetes Mellitus 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sara Al Shamimi 
Designation  Student 
Affiliation  Lovely Professional University 
Address  Department of Physiotherapy, School of Allied Medical Science, Lovely Professional University, Jalandhar Delhi GT Road, Phagwara, Punjab (India)

Jalandhar
PUNJAB
144411
India 
Phone  9508884919  
Fax    
Email  sarashamimi412@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Anahata Kaur 
Designation  Assistant Professor  
Affiliation  Lovely Professional University 
Address  Room No. 213, Block 4, Department of Physiotherapy, School of Allied Medical Science, Lovely Professional University, Jalandhar Delhi GT Road, Phagwara, Punjab (India)

Jalandhar
PUNJAB
144411
India 
Phone  8284063174  
Fax    
Email  kauranahata@gmail.com  
 
Details of Contact Person
Public Query  
Name  Sara Al Shamimi 
Designation  Student 
Affiliation  Lovely Professional University 
Address  Department of Physiotherapy, School of Allied Medical Science, Lovely Professional University, Jalandhar Delhi GT Road, Phagwara, Punjab (India)

Jalandhar
PUNJAB
144411
India 
Phone  9508884919  
Fax    
Email  sarashamimi412@gmail.com  
 
Source of Monetary or Material Support  
Department of Physiotherapy, School of Allied Medical Science, Lovely Professional University, Jalandhar Delhi GT Road, Phagwara, Punjab (India) - 144411 
 
Primary Sponsor  
Name  Sara Al Shamimi 
Address  Department of Physiotherapy, School of Allied Medical Science, Lovely Professional University, Jalandhar Delhi GT Road, Phagwara, Punjab (India) - 144411 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Anahata kaur  Lovely Professional University  Department of Physiotherapy, School of Allied Medical Science, Lovely Professional University, Jalandhar Delhi GT Road, Phagwara, Punjab (India) - 144411
Jalandhar
PUNJAB 		 8284063174

kauranahata@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC-LPU), Lovely Professional University  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E114||Type 2 diabetes mellitus with neurological complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Group A (Manual Neurodynamic Techniques + Standard Physiotherapy)  Manual Neurodynamic Techniques Participant allocated in Group A will receive manual neurodynamic mobilizations targeting tibial, peroneal and sural nerves. -Tibial Nerve: The patient will be positioned supine with the knee and hip extended. The therapist will perform ankle dorsiflexion combined with eversion and toe extension while maintaining knee extension and hip flexion. Gentle oscillatory movements will be applied to mobilize the tibial nerve. The movement sequence will invove alternating dorsiflexion and planterflexion under sustained neural tension. Each sessions, will consist of three sets of 10-15 repetitions, held for 3-5seconds, delivered three times per week for six week. - Peroneal Nerve: In the supine position with hip flexed and knee extended, the therapist will apply ankle inversion with planterflexion while maintaining knee extension and hip adduction to tension the peroneal nerve. Dynamic oscillations between inversion and eversion will be performed . Each session will include three set of 10-12 repetitions, held for 3 second, administered three times per week for six weeks. -Sural Nerve: The patient is in side lying or prone position, the therapist will perform ankle dorsoflexion and inversion with slight knee flexion, applying gentle gliding movements along the sural nerve pathway. Slow rhythmic glides will emphasize distal excursion. Each session will comprise three set of 10 repetitions, held for 5 seconds, delivered three times per week for six weeks. Standard Physiotherapy Care Participant in Group B will receive conventional physiotherapy care, including exercise therapy,gait training and foot care education. - Exercise Therapy : Strength training will be performed using resistance bands or ankle weights targeting ankle dorsiflexors, plantar flexors and intrinsic foot muscles. This aims to improve muscle strength and prevent deformity progression. Each session will consist of three sets of 10-15 repetitions, held for 3-5 seconds, conducted three times per week for six weeks. -Gait Training: Functionalmobility will be addressed through heel-to-toe walking, treadmill training and obstacle navigation exercise. These activities are designed to restore coordinated gait patterns. Each session will include three sets of 10 repetitions, performed three times per week for six weeks. -Foot Care and Education : Participants will be instructed in daily self-inspection of the feet to identify cracks, blisters or calluses, thereby preventing ulcer formation and infection. Additionally, footwear modifications will be prescribed, including cushioned insoles, wide toe boxes and pressure-relief footwear, to reduce planter pressure and protect insensitive areas. These measure will be implemented on a regular basis throughout the intervention period. 
Comparator Agent  Group B (Standard Physiotherapy)  Standard Physiotherapy Care Participant in Group B will receive conventional physiotherapy care, including exercise therapy,gait training and foot care education. - Exercise Therapy : Strength training will be performed using resistance bands or ankle weights targeting ankle dorsiflexors, plantar flexors and intrinsic foot muscles. This aims to improve muscle strength and prevent deformity progression. Each session will consist of three sets of 10-15 repetitions, held for 3-5 seconds, conducted three times per week for six weeks. -Gait Training: Functionalmobility will be addressed through heel-to-toe walking, treadmill training and obstacle navigation exercise. These activities are designed to restore coordinated gait patterns. Each session will include three sets of 10 repetitions, performed three times per week for six weeks. -Foot Care and Education : Participants will be instructed in daily self-inspection of the feet to identify cracks, blisters or calluses, thereby preventing ulcer formation and infection. Additionally, footwear modifications will be prescribed, including cushioned insoles, wide toe boxes and pressure-relief footwear, to reduce planter pressure and protect insensitive areas. These measure will be implemented on a regular basis throughout the intervention period. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  Age 40 to 70 years.
Diagnosed T2DM more than 5 years.
Clinical or electrophysiological evidence of tibial, peroneal or sural neuropathy.
Mild to moderate neuropathic signs like reduced vibration, monofilament abnormality, MRC more than 3.
HbA1c lesser or equall to 8 percent with stable glycemic control.
Able to follow instructions and provide consent. 
 
ExclusionCriteria 
Details  Peripheral vascular disease
Radiculopathy or spinal disorders
Active foot ulcers or severe neuropathy
History of lower limb surgery
Cognitive impairment or psychiatric illness
Uncontrolled diabetes or cardiovascular instability
Receiving other neurorehabilitation treatments 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Medical Research Council (MRC )Scales For Muscles Strength
2. Semmes-Weinstein monofilament test for sensory function
3. Preswsure Pain Threshold (PPT) for Neuropathic pain 		 1. 3 times
2. 3 times
3. 3 times 
 
Secondary Outcome  
Outcome  TimePoints 
1. Timed Up and Go (TUG) for mobility assessment
2. Berg Balance Scale (BBS) for Balance
3. Functional Independence Measure for Lower limb (FIM LL) for functional independence 		 1. 3 times
2. 3 times
3. 3 times 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   02/03/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [kauranahata@gmail.com].

  6. For how long will this data be available start date provided 01-01-2028 and end date provided 01-01-2033?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomized controlled trial investigates the effectiveness of Manual Neurodynamic Techniques (MNT) in improving motor and sensory recovery among patients with Type 2 Diabetes Mellitus suffering from tibial, peroneal, and sural neuropathies. Forty participants will be randomized into two groups: Group A receiving MNT plus standard physiotherapy, and Group B receiving standard physiotherapy alone. Primary outcomes include muscle strength (MRC grading), sensory function, and neuropathic pain, while secondary outcomes assess gait, balance, functional independence, and nerve conduction velocity. The study aims to address gaps in nerve-specific rehabilitation, providing evidence for integrating MNT into physiotherapy care for diabetic neuropathy. 
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