| CTRI Number |
CTRI/2024/12/077550 [Registered on: 02/12/2024] Trial Registered Prospectively |
| Last Modified On: |
26/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
The Impact of Matrix Rhythm Therapy on Hand Movement and Function After hand Surgery. |
|
Scientific Title of Study
|
The Effect of Matrix Rhythm Therapy (MaRhyThe®) on Hand Mobility and Function in Individuals with Post-Operative Hand Tendon Injuries: A Pilot Study |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Patil Aarti Bharma |
| Designation |
Post Graduated Student |
| Affiliation |
KLES Institute of Physiotherapy Belgaum |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Center Orthopedic Department room no.18 Nehru Nagar, belgavi,590010
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Center Orthopedic Department room no.18 Nehru Nagar, belgavi,590010
Belgaum
KARNATAKA
590010
India |
| Phone |
8497005106 |
| Fax |
|
| Email |
patilaarti069@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Peeyoosha Gurudat |
| Designation |
Professor and Head of Department |
| Affiliation |
KLES Institute of Physiotherapy Belgaum |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Center Orthopedic Department room no.18 Nehru Nagar, belgavi,590010
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Center Orthopedic Department room no.18 Nehru Nagar, belgavi,590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Peeyoosha Gurudat |
| Designation |
Professor and Head of Department |
| Affiliation |
KLES Institute of Physiotherapy Belgaum |
| Address |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Center Orthopedic Department room no.18 Nehru Nagar, belgavi,590010
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Center Orthopedic Department room no.18 Nehru Nagar, belgavi,590010
Belgaum
KARNATAKA
590010
India |
| Phone |
9844821355 |
| Fax |
|
| Email |
peeyooshagurudut@klekipt.edu.in |
|
|
Source of Monetary or Material Support
|
| kaher institute of physiotherapy nehru nagar belgavi 590010 |
|
|
Primary Sponsor
|
| Name |
Patil Aarti Bharma |
| Address |
KLES institute of physiotherapy nehru nagar belgavi 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 |
| Patil Aarti Bharma |
KLES Dr. Prabhakar Kore Hospital and MRC Nehru Nagar, Belgavi, 590010 |
KLES Dr. Prabhakar Kore Hospital and MRC, Advanced Physiotherapy Center Orthopedic Department room no.18 Nehru Nagar, belgavi,590010
Belgaum
KARNATAKA |
08497005106
patilaarti069@gmail.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: M662||Spontaneous rupture of extensor tendons, (2) ICD-10 Condition: M663||Spontaneous rupture of flexor tendons, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Matrix Rhythm Therapy (MaRhyThe®) |
6-months study
application of Matrix Rhythm Therapy (MaRhyThe®) in Individuals with Post-Operative Hand Tendon Injuries |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1. Age group: 18–60 years, with post-operative tendon injuries in the hand.
2. All genders are eligible to participate.
3. Referred cases of post-operative hand tendon injuries with a 6 to 8-week post-operative duration.
4. Participants with either flexor or extensor tendon injuries in the hand, at any zone, accompanied by hand mobility and function following a post-operative procedure.
5. Participants are willing to take part in the study and be able to understand instructions.
|
|
| ExclusionCriteria |
| Details |
1. history of tendon surgeries performed more than a year ago, especially those who experienced severe complications such as contracture.
2. Participants with flexor or extensor tendon injuries of the hand, particularly when accompanied by fractures, will not be eligible for a part in the study.
3. Participants with uncontrolled diabetes or other autoimmune disorders that could interfere with the healing process will be excluded from the study.
4. Participants planning for secondary surgery due to tendon adhesion will be excluded from the study.
5. Participants presenting with fever, swelling, non-healing wounds, open, inflamed, or infected skin surfaces or a tendency to bleed will be excluded from the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Range of Motion- hand and finger |
1. Range of Motion- hand and finger- measure in degrees
Time points: pre-intervention and post-intervention, assessed over two weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Hand function: Action research arm test.
2. Pain: Numeric pain rating scale
Time points: pre-intervention and post-intervention, assessed over two weeks. |
1. Action Research arm test-score 0-57
2. Numeric pain rating scale- score 0-10
Time points: pre-intervention and post-intervention, assessed over two weeks. |
|
|
Target Sample Size
|
Total Sample Size="10"
Sample Size from India="10"
Final Enrollment numbers achieved (Total)= "10"
Final Enrollment numbers achieved (India)="10" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
11/12/2024 |
| Date of Study Completion (India) |
02/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/05/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
SUMMARY OF THE PROPOSED RESEARCH Hand tendon injuries, which can result from various accidents, lead to significant pain and functional impairment. Matrix Rhythm Therapy enhances tissue healing by restoring optimal cellular function through specific vibrational frequencies. The aim will be to determine how Matrix Rhythm Therapy impacts hand mobility, assessed via wrist ROM, functional capabilities measured by the Action Research Arm Test, and pain levels evaluated using the Numeric Pain Rating Scale. Data collection will occur over 6 months at a tertiary care hospital in Belagavi city, involving 10 participants aged 18-60 with flexor or extensor tendon injuries. Participants will receive 4 sessions of Matrix Rhythm Therapy over 2 weeks, each lasting 60 minutes. Pre- and post-intervention assessments will measure hand mobility, function, and pain. The research is expected to show that Matrix Rhythm Therapy enhances hand mobility and function while reducing pain, potentially supporting its integration into rehabilitation protocols for hand tendon injury recovery. |