| CTRI Number |
CTRI/2025/02/080384 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Muscle Release Therapy versus Sensory Stimulation Therapy on Muscle Stiffness and Arm Movement in Stroke Patients |
|
Scientific Title of Study
|
Comparison of myofascial release versus roods approach on spasticity and motor function of upper limb in stroke patient. |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
JYOTHI KESTI |
| Designation |
post-graduate student |
| Affiliation |
dayananda sagar university - college of physiotherapy |
| Address |
Dayananda Sagar University School of Health Sciences- department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara
Department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara, Karnataka 562112
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
7892112872 |
| Fax |
|
| Email |
jyothikesti31@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DRVINOD KUMAR K C |
| Designation |
Associate professor |
| Affiliation |
dayananda sagar university - college of physiotherapy |
| Address |
Dayananda Sagar University School of Health Sciences- department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara.
Department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara, Karnataka 562112
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
9036200878 |
| Fax |
|
| Email |
vinod-mpt@dsu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
DRVINOD KUMAR K C |
| Designation |
Associate professor |
| Affiliation |
dayananda sagar university - college of physiotherapy |
| Address |
Dayananda Sagar University School of Health Sciences-department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara, Karnataka 562112
department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara, Karnataka 562112
Bangalore Rural
KARNATAKA
562112
India |
| Phone |
9036200878 |
| Fax |
|
| Email |
vinod-mpt@dsu.edu.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
jyothi kesti |
| Address |
Dayananda Sagar University School of Health Sciences- Physiotherapy devarakaggalahalli Ramanagara-562112 |
| Type of Sponsor |
Other [jyothi kesti (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 Vinod Kumar K C |
Dayananda sagar university - college of physiotherapy |
department of physiotherapy Devarakaggalahalli, Harohalli Kanakapura Road, Dt, Ramanagara, Karnataka 562112
Bangalore Rural
KARNATAKA |
9036200878
vinod-mpt@dsu.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| dayananda sagar university - institutional ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I679||Cerebrovascular disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
MYOFASCIAL RELEASE |
Myofascial release with a tennis ball for affected upper extremity muscles for 6 minutes along with conventional therapy for 45 mins which includes Rom, strengthening exercise for upper limb and lower limb and functional training for upper limb. |
| Comparator Agent |
NIL |
NIL |
| Intervention |
ROODS APPROACH |
roods inhibitory techniques such as maintained stretch, tendinous pressure and weight bearing for affected upper extremity for duration of 7 minutes along with conventional therapy for 45 mins which includes Rom, strengthening for upper limb and lower limb and functional training for upper limb. |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
a)Patients who came voluntarily and signed the informed consent
b)MAS Grade 1-3
c)MMSE score more than 24
d)Both ischemic and haemorrhagic stroke
e)3–5 stage of recovery of voluntary control according to Brunnstrom stages for shoulder, elbow, and wrist joints
f)Participants suffering from unilateral stroke dysfunction in chronic stage ( 6 months after the onset)
|
|
| ExclusionCriteria |
| Details |
1.complex regional pain syndrome
2.severe cognitive impairment,
3.impaired sensation over the affected upper limb, recently injured area/open wounds
4.arthritic or any other musculoskeletal condition of the upper extremity,
5.Botox injection in the past 4 months,
6.Unilateral neglect
7.shoulder instability based on the posterior or anterior apprehension test, and positive sulcus test
8.Multiple strokes
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Modified Ashworth scale
2.Fugl Meyer assessment scale for upper extremity |
pre( 0 week), post(6 weeks), 1 month post termination of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Limb length, limb girth, voluntary control grading |
0 Weeks & 6 weeks |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="36"
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)
|
28/02/2025 |
| 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="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
The study aims to compare the effectiveness of myofascial release (MFR) and the Rood’s sensory-motor approach in reducing spasticity and improving motor functions in the upper limbs of stroke patients. Myofascial release involves sustained pressure to relieve muscle adhesions and restore tissue flexibility, while the Rood’s approach utilizes sensory stimulation to modulate neuromuscular responses. The hypothesis posits a significant difference (alternative hypothesis) in outcomes between these techniques, though the null hypothesis assumes no such difference. The randomized comparative study will evaluate chronic stroke patients over six weeks, employing measures like the Modified Ashworth Scale and Fugl-Meyer Assessment to assess spasticity and motor function improvements. |