| 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
|
|
|
Primary Sponsor
|
| Name |
Shreya Pande |
| Address |
KLE Institute of Physiotherapy, Nehru Nagar, Belagavi, 590010 |
| Type of Sponsor |
Other [Self ] |
|
|
Details of Secondary Sponsor
|
|
|
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
|
|
|
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
|
|
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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
|
|
|
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. |