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CTRI Number  CTRI/2026/01/101268 [Registered on: 15/01/2026] Trial Registered Prospectively
Last Modified On: 12/01/2026
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   evaluating the impact of exercise protocol called rhythmic amplitude motor progression on diabetic patients who have neuropathy to evaluate their balance and walking pattern 
Scientific Title of Study   Evaluating the Impact Rhythmic-Amplitude Motor Progression (RAMP) Protocol on Gait, Balance, Endurance, and Functional Mobility in Individuals with Diabetic Peripheral Neuropathy:A Multicentric Double-Blind Randomized Controlled Trial 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  SUNJYOTH H S 
Designation  Assistant Professor  
Affiliation  college of physiotherapy , Dayananda Sagar University  
Address  Neurophysiotherapy Department College of Physiotherapy ,Dayananda sagar university devarakaggalahalli, harohalli, kanakapura main road, karnataka
devarakaggalahalli, harohalli, kanakapura main road, karnataka
Bangalore
KARNATAKA
562112
India 
Phone  8722555859  
Fax    
Email  sanjyoth05@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  SUNJYOTH H S 
Designation  Assistant Professor  
Affiliation  college of physiotherapy , Dayananda Sagar University  
Address  Neurophysiotherapy department , college of physiotherapy devarakaggalahalli, harohalli, kanakapura main road, karnataka
devarakaggalahalli, harohalli, kanakapura main road, karnataka
Bangalore
KARNATAKA
562112
India 
Phone  8722555859  
Fax    
Email  sanjyoth05@gmail.com  
 
Details of Contact Person
Public Query  
Name  SUNJYOTH H S 
Designation  Assistant Professor  
Affiliation  college of physiotherapy , Dayananda Sagar University  
Address  Neurophysiotherapy department, College of Physiotherapy devarakaggalahalli, harohalli, kanakapura main road, karnataka
devarakaggalahalli, harohalli, kanakapura main road, karnataka
Bangalore
KARNATAKA
562112
India 
Phone  8722555859  
Fax    
Email  sanjyoth05@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  college of physiotherapy,Dayananda sagar university 
Address  devarakaggalahalli, harohalli, kanakapura main road, karnataka 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 2  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
SUNJYOTH H S  Abhijnya Physiotherapy and Wellness Clinic  Mezzanine floor, Vasanth Chambers, Beside Besant Commercial premisis,Mangalore
Dakshina Kannada
KARNATAKA 		 8722555859

sanjyoth05@gmail.com 
SUNJYOTH H S  college of physiotherapy , Dayananda Sagar University  devarakaggalahalli, harohalli, kanakapura main road, karnataka
Bangalore
KARNATAKA 		 8722555859

sanjyoth05@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE  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 
Comparator Agent  Conventional Physiotherapy  The control group will receive conventional physiotherapy that includes a 5 minute warm-up with breathing exercises and light ankle pumps followed by static balance training such as tandem standing and single-leg stance with support for 3 sets of 30 seconds each. Range of motion and strengthening exercises including ankle/toe circles, seated knee extensions, and heel raises will be performed for 3 sets of 10 repetitions. Gait practice will involve 10 minutes of normal walking on an indoor surface, followed by sit-to-stand training at a normal pace for 2 sets of 10 repetitions, and the session will conclude with 5 minutes of stretching focused on the hamstrings and calf muscles. 
Intervention  intervention group:Rythmic amplitude motor progression training Control group:Conventional Physiotherapy  to the intervention group Rhythmic-Amplitude Motor Progression (RAMP) is a 6week amplitude-based mobility program integrating rhythmic auditory cueing, task-specific movement retraining, and cognitive strategies to improve gait, balance, endurance, and functional mobility in individuals with diabetic peripheral neuropathy. The protocol is structured in three phases: Weeks 1 and 2 focus on familiarization with BIG movements through metronome-based in-place stepping (80 BPM), seated amplitude arm swings, sit-to-stand with verbal cueing, early dual-task marching with backward counting, and basic stretching. Weeks 3 and 4 emphasize progression of gait quality with metronome-paced walking (90–100 BPM), obstacle step-overs, diagonal marching, auditory cue drills, and object-carry dual tasks. Weeks 5 and 6 target integration and endurance using rhythmic gait circuits (110 BPM), functional daily-life task circuits, speed-switch walking, and word-recall dual tasks. Cognitive strategies are embedded throughout including self-instruction cues (“BIG step”), posture awareness, visual markers, dual-tasking with increasing cognitive load, and brief mental rehearsal to enhance motor learning and real-world carryover. 
 
Inclusion Criteria  
Age From  45.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Participants will include individuals who are currently on medication for diabetes. Eligible participants must present sensory impairment with an MNSI score of equal or more 2.5 points and have the ability to walk household distances without assistance. Additionally, participants should have ankle muscle power greater than MRC grade 3 and a Berg Balance Scale (BBS) score of more than 21. 
 
ExclusionCriteria 
Details  Participants will be excluded if they have a foot ulcer at the time of intake, any orthopedic condition that influences gait, or neurological problems other than diabetic peripheral neuropathy. Individuals with vestibular disorders, diabetic retinopathy, or middle ear infections that may affect balance or gait will also be excluded. Additionally, patients with uncontrolled cardiovascular or respiratory disorders will not be eligible to participate. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Double Blind Double Dummy 
Primary Outcome  
Outcome  TimePoints 
10MWT
BBS
6MWT 		 Pre and Post intervention  
 
Secondary Outcome  
Outcome  TimePoints 
ABC
TUG
DGI 		 Pre and Post intervention  
 
Target Sample Size   Total Sample Size="66"
Sample Size from India="66" 
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)   30/01/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  30/01/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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  

I am conducting a randomized controlled trial on individuals with diabetic peripheral neuropathy aged between 45 and 65 years. Participants will be randomly assigned to either a control group receiving standardized physiotherapy or an experimental group receiving the RAMP protocol. The intervention will be delivered for 6 weeks, three sessions per week. Outcome measures will be assessed before and after the intervention. The primary outcomes include the 10-Meter Walk Test (10MWT), 6-Minute Walk Test (6MWT), and Berg Balance Scale (BBS). The secondary outcomes include the Dynamic Gait Index (DGI), Activities-specific Balance Confidence Scale (ABC), and Timed Up and Go Test (TUG).

 
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