| CTRI Number |
CTRI/2024/02/062703 [Registered on: 15/02/2024] Trial Registered Prospectively |
| Last Modified On: |
09/02/2024 |
| 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
|
Enhancing Stroke Recovery: Scapular and Trunk Stability Exercises for Improved Upper Extremity Function |
|
Scientific Title of Study
|
Effect of scapular and trunk stability exercises on upper extremity functions among stroke individuals. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Jennifer Massey |
| Designation |
PG Student |
| Affiliation |
Amity Institute of Health and Allied Sciences, Amity university |
| Address |
Lower ground floor, F1 block, Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9953098774 |
| Fax |
|
| Email |
jennimassey98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ankit Jain |
| Designation |
Assistant professor |
| Affiliation |
Amity Institute of Health and Allied Sciences, Amity University |
| Address |
F1 block, Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Sector 125, Noida, Uttar Pradesh
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9999600611 |
| Fax |
|
| Email |
ajain@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Ankit Jain |
| Designation |
Assistant professor |
| Affiliation |
Amity Institute of Health and Allied Sciences, Amity University |
| Address |
F1 block, Department of Physiotherapy, Amity Institute of Health and Allied Sciences, Amity University, Sector 125, Noida, Uttar Pradesh
UTTAR PRADESH
201313
India |
| Phone |
9999600611 |
| Fax |
|
| Email |
ajain@amity.edu |
|
|
Source of Monetary or Material Support
|
| Amity OPD amity university gate no 1 Noida sector 125 Uttar Pradesh 201313 |
| DS Spine Clinic NDMC A-1/87 NDNC
Diagnostic basement Dwarka Mor Block B1 Sewak Park New Delhi 110059 |
|
|
Primary Sponsor
|
| Name |
Jennifer Massey |
| Address |
Lower ground floor, F1 block, Department of Physiotherapy, Amity Institute of Health Allied Sciences, Amity University, Sector 125, Noida, Uttar Pradesh |
| 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 Ankit Jain |
Amity OPD |
Amity university gate no 1 Noida
Uttar Pradesh 201313
Gautam Buddha Nagar
UTTAR PRADESH |
09999600611
ajain@amity.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional NTCC committee, Amity Institute of Health and Allied Sciences, Amity University uttar pradesh |
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, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1. upper extremity exercises |
TheraBand exercises
Shoulder extension
Shoulder flexion
Note- progressed by increasing the resistance of the bands
Elbow and wrist -
Passive ROM exercises
Elbow flexion and extension
Shoulder flexion and extension
Finger and wrist flexion and extension
Weight bearing exercises
Push down physio ball
Push up on armrest chair |
| Intervention |
1.upper extremity exercises
2.trunk stability exercises
3.scapula stability exercises |
1. upper extremity exercises
TheraBand exercises
Shoulder extension
Shoulder flexion
Note- progressed by increasing the resistance of the bands
Elbow and wrist -
Passive ROM exercises
Elbow, flexion and extension
Shoulder, flexion and extension
Finger and wrist flexion and extension
Weight bearing exercises
Push down physio ball
Push up on armrest chair
2. trunk stability exercises
anteversion-retroversion
pelvis
Upper trunk rotation
Lower trunk rotation
Lower trunk flexion
3. scapula stability exercises
prone hori. Abduct.
Prone hori. Scapation
Prone hori. ext. Rotation
Prone hori. Extension
|
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Diagnosis of Stroke: Individuals with a documented medical history of MCA Ischemic stroke.
2.Age Range: Adults within a specific age range, such as 40 to 60 years.
3.Time Since Stroke: Participants who have experienced a stroke within a defined timeframe, after discharge to 2 years.
4.Upper Extremity Impairment: such as muscle weakness, limited range of motion, or coordination deficits, confirmed through clinical evaluation.
5.Cognitive Ability: Individuals with cognitive functioning and communication skills sufficient to understand and follow exercise instructions.
6.Willingness to Participate: Individuals who express a willingness and commitment to participate in the study.
7.Informed Consent: Individuals who provide informed written consent to participate in the study.
|
|
| ExclusionCriteria |
| Details |
1.Severe Medical Complications: Individuals with severe medical complications.
2.Uncontrolled Cardiovascular Conditions: Participants with uncontrolled cardiovascular conditions.
3.Upper Extremity Surgeries: Participants who have undergone recent upper extremity surgeries or procedures that could interfere with the study intervention or outcomes.
4.Other Rehabilitation Programs: Individuals currently participating in other upper extremity rehabilitation programs or interventions that could influence the study outcomes.
5.Pregnancy: Pregnant individuals, as physical exercise interventions may need to be modified for this population.
6.Unstable Psychological Conditions: Participants with unstable or severe psychological conditions that could hinder their ability to adhere to the exercise protocol or affect study outcomes.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| ROM, DASH questionnaires, FMA, SF 36, MoCA SCORE. |
ROM - baseline, 3rd week, 6th week
DASH questionnaires-baseline, 3rd week, 6th week
FMA-baseline, 3rd week, 6th week
SF 36-baseline, 3rd week, 6th week
MoCA SCORE-baseline, 3rd week, 6th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="68"
Sample Size from India="68"
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)
|
20/02/2024 |
| 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="3"
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
|
This research endeavors to investigate the impact of scapular and trunk stability exercises on the upper extremity functions of individuals who have experienced a stroke. The primary objectives include enhancing motor recovery, increasing range of motion, and improving overall functional independence and quality of life for stroke survivors. Through a meticulous selection process, a sample size of 68 participants is included in the study, with clear criteria for inclusion and exclusion. The experimental design involves two distinct groups: Group 1, designated as the exercise group, and Group 2, the control group. The exercise group undergoes targeted scapular and trunk stability exercises, while the control group does not receive these interventions. This comparative approach facilitates an in-depth analysis, assessing the specific impact of the exercises on upper extremity functions in the context of stroke recovery. The ultimate goal is to generate findings that can inform evidence-based rehabilitation protocols, guiding healthcare practitioners in the development of more effective and tailored interventions for individuals who have experienced a stroke. The study’s emphasis on rigorous participant selection ensures a focused and meaningful contribution to the broader field of stroke rehabilitation. |