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CTRI Number  CTRI/2026/03/105226 [Registered on: 02/03/2026] Trial Registered Prospectively
Last Modified On: 23/02/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Other 
Public Title of Study   Effect of super inductive system therapy combined with mCIMT on spastic hand in stroke patients. 
Scientific Title of Study   EFFECT OF SUPER INDUCTIVE SYSTEM THERAPY COMBINED WITH MCIMT ON SPASTIC HAND IN STROKE PATIENTS– A SINGLE BLINDED, 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  Shreya Pande 
Designation  Post Graduate Student  
Affiliation  KLE Institute of Physiotherapy 
Address  KLE Institute of Physiotherapy, Nehru Nagar, Belagavi, 590010

Belgaum
KARNATAKA
590010
India 
Phone  7768065544  
Fax    
Email  drshreyapande@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Sanjiv Kumar 
Designation  Head of Department of Neurology Physiotherapy 
Affiliation  KLE Institute of Physiotherapy 
Address  KLE Institute of Physiotherapy, Nehru Nagar, Belagavi, 590010

Belgaum
KARNATAKA
590010
India 
Phone  9448745648  
Fax    
Email  sanjiv3303@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Shreya Pande 
Designation  Post Graduate Student  
Affiliation  KLE Institute of Physiotherapy 
Address  KLE Institute of Physiotherapy, Nehru Nagar, Belagavi, 590010

Belgaum
KARNATAKA
590010
India 
Phone  7768065544  
Fax    
Email  drshreyapande@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Shreya Pande  
Address  KLE Institute of Physiotherapy, Nehru Nagar, Belagavi, 590010 
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 Sanjiv Kumar  KLES Dr. Prabhakar Kore Hospital and MRC  Advanced Physiotherapy Centre, Nehru Nagar, Belagavi- 590010
Belgaum
KARNATAKA 
9448745648

sanjiv3303@rediffmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Research and ethical committee KLEU institute of physiotherapy.   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G811||Spastic hemiplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Modified constraint induced movement therapy   The modified constraint-induced movement therapy protocol will be administered for a total duration of 2 weeks. Participants will undergo a constraint time of 5 hours per day, during which the less-affected upper limb will be restrained to promote active use of the affected limb. Within this daily constraint period, 30 minutes will be dedicated to structured functional task practice focusing on goal-directed upper limb activities. The type of constraint that will be used to restrict the less-affected hand will include a mitt, glove, or splint, selected based on participant comfort and suitability. This approach will ensure consistent immobilization of the unaffected limb while facilitating intensive, task-specific training of the affected upper extremity. 
Intervention  Super Inductive System   The intensity will be determined individually for each patient at the beginning of every session and will be gradually increased up to the motor threshold. It will correspond to 15–25% of the device’s maximum intensity, which is 2.5 Tesla. The stimulation frequency for the agonist muscles will be a fixed frequency of 1 Hz, while the antagonist muscles will receive a constant frequency of 150 Hz. The technique will involve a non-contact application, with the applicator positioned 1–2 cm away from the skin surface. The total time duration per session will be 9 minutes, comprising 1 minute of stimulation for the agonist muscles and 8 minutes for the antagonist muscles. A total of 6 sessions will be conducted over a period of 2 weeks. This intervention will be administered in conjunction with modified Constraint-Induced Movement Therapy. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  1. Participants of all genders from the age group of 18 to 75 years who are
willing to participate.
2. With a score of more than grade 1 of Modified Ashworth scale.
3.With a score of more than grade 1 of Brunnstrom Stages Of Stroke Recovery.
4.Participants who shows at least 10° of active wrist extension, 10 degree of thumb
abduction/extension, and 10 degree of extension in at least 2 additional digits on
ipsilateral side. 
 
ExclusionCriteria 
Details  1.Other Neurological Conditions.
2.Other conditions affecting hand function like Burns, Rheumatoid Arthritis, Leprosy, Diabetic neuropathy.
3.Acute cardiac conditions.
4.Metallic implants, Cancer, Fever, Pregnancy
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Modified ashworth scale
2. fugl meyer assessment for upper extremity.
3. Nine hole peg test
4. Goniometry
5. DASH questionnaire
 
At the baseline and at the end of the intervention (after 2 weeks) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL   
 
Target Sample Size   Total Sample Size="16"
Sample Size from India="16" 
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)   07/03/2026 
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="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  

This study aims to investigate the effect of Super Inductive System (SIS) therapy combined with modified Constraint-Induced Movement Therapy (mCIMT) on hand spasticity and upper limb function in individuals with stroke. Post stroke spasticity is a common and disabling motor disorder that limits functional independence, reduces quality of life, and leads to secondary complications such as contractures, pain, and pressure sores. Although conventional physiotherapy, pharmacological management, and invasive procedures are available, they often provide only short term benefits or have limitations related to cost, accessibility, and adverse effects.

mCIMT is an evidence based intervention that promotes use of the affected limb through intensive task specific training and restraint of the unaffected limb, thereby enhancing neuroplasticity and functional recovery. However, its direct effect on spasticity is limited, especially in patients with marked hypertonia. SIS therapy is a recent, non invasive modality that uses high intensity electromagnetic stimulation to induce controlled muscle contractions, improve circulation, modulate neuromuscular activity, and reduce muscle tone. The combined application of SIS and mCIMT is expected to produce complementary effects by reducing spasticity physiologically while simultaneously promoting motor relearning and functional use of the hand.

This single-blinded randomized controlled trial will be conducted on 16 stroke patients recruited from a tertiary care hospital and allocated into two groups: mCIMT alone and SIS with mCIMT. The intervention will be administered over two weeks. Outcomes will be measured using the Modified Ashworth Scale, Fugl-Meyer Assessment for Upper Extremity,  Nine Hole Peg Test, goniometry, and the DASH questionnaire.

The study intends to establish an effective, non invasive, multimodal rehabilitation approach for improving hand function, dexterity, and quality of life in stroke survivors.

 
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