| CTRI Number |
CTRI/2025/06/089393 [Registered on: 24/06/2025] Trial Registered Prospectively |
| Last Modified On: |
24/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Improving Nerve and Muscle Function in Diabetes: A Study Comparing Three Physiotherapy Methods |
|
Scientific Title of Study
|
Comparison of Lagos Neuropathy Protocol, Proprioceptive Neuromuscular Facilitation and Neuromuscular Taping on Sensorimotor Functions in Diabetic Peripheral Neuropathy |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Adarsh |
| Designation |
Ph.D. Scholar (Physiotherapy) |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU) |
| Address |
Department of Physiotherapy, Neurophysiotherapy Research Laboratory, Room No. B-14, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
9896243766 |
| Fax |
|
| Email |
adarshsharma476@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Akanksha Saxena |
| Designation |
Associate Professor |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU) |
| Address |
Department of Physiotherapy, Neurophysiotherapy Research Laboratory, Room No. B-14, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
7906989678 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Adarsh |
| Designation |
Ph.D. Scholar (Physiotherapy) |
| Affiliation |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, MM(DU) |
| Address |
Department of Physiotherapy, Neurophysiotherapy Research Laboratory, Room No. B-14, Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana
Ambala
HARYANA
133203
India |
| Phone |
9896243766 |
| Fax |
|
| Email |
adarshsharma476@gmail.com |
|
|
Source of Monetary or Material Support
|
| Amar Jyoti Institute of Physiotherapy (University of Delhi), Vikas Marg, Karkardooma, Delhi-110092 |
|
|
Primary Sponsor
|
| Name |
Adarsh |
| Address |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Maharishi Markandeshwar (Deemed to be University), Mullana, Ambala, Haryana-133203 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Adarsh |
H.No. 6, Vishal Nagar, Near Chopra Garden, Yamunanagar, Haryana-135001 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Savita Kataria |
Amar Jyoti Rehabilitation and Research Centre |
Department of Physiotherapy, 3rd Floor Physiotherapy Research Laboratory No.2, Amar Jyoti Institute of Physiotherapy, Amar Jyoti Charitable Trust, Vikas Marg, Karkardooma, Delhi-110092
East
DELHI |
9810081074
savitakpc@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Amar Jyoti Institute of Physiotherapy Institutional Review Board-Ethical Committee (AJIRB-EC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E134||Other specified diabetes mellituswith neurological complications, (2) ICD-10 Condition: G63||Polyneuropathy in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Lagos Neuropathy Protocol (LNP) |
Intervention: A 10-station protocol will be given to each individual in Group 1. Intervention duration: 45 minutes for each session. Intervention period: 3 days/week for 10 weeks |
| Intervention |
Neuromuscular Taping (NMT) |
Patient position: Supine lying Therapist position: Standing on the side of the patient Intervention: NMT will be done for Group 3 individuals at the tibialis posterior, tibialis anterior, peroneus longus muscles, and medial arch of the foot. Intervention Duration: 45 minutes Duration of Taping for per session: 3 days Intervention Period: 3 days/week for 10 weeks. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Proprioceptive Neuromuscular Facilitation (PNF) |
Patient position: Supine lying Therapist position: Standing on the side of the patient Intervention: The proprioceptive neuromuscular facilitation (PNF) patterns of diagonal movement will be given to Group 2 individuals, were referred to as the diagonal 1 (D1) and diagonal 2 (D2) patterns. These diagonal patterns are subdivided into D1 moving into flexion, D1 moving into extension, D2 moving into flexion, D2 moving into extension. Technique of Application: Rhythmic Initiation technique will be used for all PNF patterns. Intervention Duration: 45 minutes for each session. Intervention period: 3 days/week for 10 weeks. |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Both males and females 60-75 years of age.
Referred cases of type 1 and 2 DM-induced sensory and motor lower extremity DPN.
Duration of diabetes above 5 years.
HbA1c levels 6.5-10
Patients on insulin or OHA drugs.
BMI: 18.5-29.9
Michigan neuropathy screening instrument (MNSI) score 2.5.
BBS score less than 45
LANSS Scale more than 12
Patients provided informed consent.
MMSE score more than 24
|
|
| ExclusionCriteria |
| Details |
Individuals with any systemic manifestations other than diabetes like stroke, SCI, tuberculosis, etc.
Diabetic ulcer in either foot.
Significant musculoskeletal disorder of lower limbs (amputation, fracture, strain, sprain), any surgery of lower limbs.
Diagnosed psychiatric disorders such as schizophrenia, psychosis etc.
Patients having advanced knee OA.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
LANSS Pain Scale
Berg Balance Scale (BBS)
Position-Reposition Test
Lower Limb Matching Test and Sense of Movement Test |
LANSS Pain Scale (Baseline and 10th week)
Berg Balance Scale (BBS) (Baseline and 10th week)
Position-Reposition Test (Baseline and 10th week)
Lower Limb Matching Test and Sense of Movement Test (Baseline and 10th week) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Gait On Running Gait Analysis Software |
Gait On Running Gait Analysis Software (Baseline, 10 weeks) |
|
|
Target Sample Size
|
Total Sample Size="45"
Sample Size from India="45"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/07/2025 |
| 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="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
Introduction: The management of diabetic
peripheral neuropathy (DPN) consists of multidirectional interventions.
Physiotherapy, in addition to the pharmacological approach, has achieved
appreciable popularity in ameliorating the symptoms of DPN. Lagos neuropathy
protocol (LNP), proprioceptive neuromuscular facilitation (PNF), and
neuromuscular taping (NMT), have shown remarkable improvements in sensorimotor
impairments in various neuromuscular and musculoskeletal disorders. Still, no
research has been established to compare the effectiveness of LNP, PNF and NMT
on sensorimotor functions in individuals with DPN.
Aim: To compare the effectiveness of
LNP, PNF and NMT on sensorimotor functions in patients with diabetic peripheral
neuropathy.
Materials and
Methods: 60 DPN
subjects 60-75 years of age both male and female will be divided into 3 groups,
scored more than 2/13 on physical appearance and more than 1/10 on physical examination of the
Michigan Neuropathy Screening Instrument (MNSI), less than 45 on Berg Balance Scale
(BBS) and more than 12 on Leeds Assessment of Neuropathic Symptom and Sign (LANSS)
scale) will be included in the study. All three groups (LNP, PNF, and NMT) will
receive an intervention for 3 days/week for 10 weeks respectively. Outcome
measures will be assessed at baseline and post-intervention, respectively. |