| CTRI Number |
CTRI/2025/03/083701 [Registered on: 28/03/2025] Trial Registered Prospectively |
| Last Modified On: |
26/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Physiotherapy (Not Including YOGA) |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To check if additional scapulothorasic exercises could aid in better recovery with respect to scapular mobility, shoulder, elbow and hand function, ability to control the trunk. |
|
Scientific Title of Study
|
EFFECTIVENESS OF ADDITIONAL
SCAPULOTHORACIC REHABILITATION
EXERCISES ON SENSORIMOTOR FUNCTION,
TRUNK CONTROLAND ON SCAPULAR MOBILITY
IN ACUTE STROKE SUBJECTS:
A 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 |
Ryan Theckel Thomas |
| Designation |
Post-Graduate |
| Affiliation |
Kasturba Medical College, Mangalore |
| Address |
Department of Physiotherapy, Centre for Basic Sciences, Kasturba Medical College, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9397909098 |
| Fax |
|
| Email |
ryan.mchpmlr2024@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Akshatha Nayak M |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Physiotherapy, Centre for Basic Sciences, Kasturba Medical College, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986054034 |
| Fax |
|
| Email |
akshatha.nd@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Akshatha Nayak M |
| Designation |
Assistant Professor- Selection Grade |
| Affiliation |
Kasturba Medical College, Mangalore, Manipal Academy of Higher Education, Manipal |
| Address |
Department of Physiotherapy, Centre for Basic Sciences, Kasturba Medical College, Bejai, Mangalore
Dakshina Kannada
KARNATAKA
575004
India |
| Phone |
9986054034 |
| Fax |
|
| Email |
akshatha.nd@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of physiotherapy KMC Mangalore 575001 |
|
|
Primary Sponsor
|
| Name |
Ryan T Thomas |
| Address |
Department of physiotherapy Kasturba Medical College
Mangalore
575004 |
| 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 Akshatha Nayak |
Kasturba Medical College and hospitals, Mangalore |
Dr.B, R.Ambedkar Circle, Hampankatta, Mangaluru, Karnataka 575001
Dakshina Kannada
KARNATAKA |
9986054034
akshatha.nd@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee Kasturba Medical College Mangalore |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I633||Cerebral infarction due to thrombosis of cerebral arteries, (2) ICD-10 Condition: I601||Nontraumatic subarachnoid hemorrhage from middle cerebral artery, (3) ICD-10 Condition: I629||Nontraumatic intracranial hemorrhage, unspecified, (4) ICD-10 Condition: I602||Nontraumatic subarachnoid hemorrhage from anterior communicating artery, (5) ICD-10 Condition: I603||Nontraumatic subarachnoid hemorrhage from posterior communicating artery, (6) ICD-10 Condition: I610||Nontraumatic intracerebral hemorrhage in hemisphere, subcortical, (7) ICD-10 Condition: I612||Nontraumatic intracerebral hemorrhage in hemisphere, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional stroke rehabilitation |
Participants will recieve 40 minutes of Conventional stroke rehabilitation that includes exercises for restoring motor control of limbs and trunk, balance and gait training. |
| Intervention |
scapulothoracic rehabilitation |
Participant of Group A will receive 20 minutes of scapulothoracic stabilization along with 40 minute of conventional physiotherapy treatment. Depending on subject’s performance, the exercises will be progressed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1. Clinically stable stroke subjects with first episode of supratentorial stroke.
2. Patients with BRS upper limb staging of 3 to 6.
3. Moca score of 26 and above |
|
| ExclusionCriteria |
| Details |
1. Patients with previous shoulder pathologies, pre existing musculoskeletal issues or cardiovascular conditions affecting the assessment and treatment..
2. Patients diagnosed with other neurological disorders.
3. Patients with hemi neglect, pusher’s syndrome, severe visual field defects and somato-sensory deficit. |
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Upper Limb Sensorimotor Function |
Pre and Post Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Scapular Mobility |
Pre and Post Intervention |
| Trunk Control |
Pre and Post Intervention |
|
|
Target Sample Size
|
Total Sample Size="46"
Sample Size from India="46"
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
06/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
06/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="1"
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
|
The study is aimed at identifying the effect of scapular thoracic rehabilitation in patients with acute episode of stroke and its effect on upper limb sensorimotor function and the scapular mobility. We intend to recruit patients with a 1st acute episode of stroke , screen the patients using MOCA those with a mild cognitive deficit will be further considered and included after which those fulfilling the inclusion criteria will be randomized into two groups i.e. Group A and Group B. Following that subjects will be allocated according by block randomization with 7 blocks of 6 subjects and 1 block of 4 subjects, Group A participants will receive Scapular thoracic rehabilitation along with conventional therapy and group B participants will receive conventional therapy alone. Prior to treatment the subjects will be assessed using the Fugl-Meyer upper extremity to asses the upper limb sensorimotor function and the palpation meter for the scapular mobility. The subjects will receive 2 weeks of rehabilitation after which the same outcome measures will be used post the intervention.
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