| CTRI Number |
CTRI/2025/08/093939 [Registered on: 29/08/2025] Trial Registered Prospectively |
| Last Modified On: |
29/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Correlational study |
| Study Design |
Other |
|
Public Title of Study
|
Study of how Neck Movement and Awareness Affect Balance in People Living with Stroke |
|
Scientific Title of Study
|
The Relationship between Cervical range of motion, Cervical proprioception and Balance in patients with chronic stroke- A Correlational 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 |
Dr Sharayoo Salve |
| Designation |
Post Graduate Student |
| Affiliation |
YMT College of Physiotherapy |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9372916466 |
| Fax |
|
| Email |
sharayoosalve@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ramesh Natrayan |
| Designation |
HOD , Professor |
| Affiliation |
Professor at YMT College of Physiotherapy , Dr. G.D Pol Foundation |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
NIL
Raigarh
MAHARASHTRA
410210
India |
| Phone |
7874856011 |
| Fax |
NIL |
| Email |
natraam@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sharayoo Salve |
| Designation |
Post Graduate Student |
| Affiliation |
YMT College of Physiotherapy |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA
410210
India |
| Phone |
9372916466 |
| Fax |
|
| Email |
sharayoosalve@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Sharayoo Salve |
| Address |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210 |
| 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 Sharayoo Salve |
YMT College of Physiotherapy |
Dr. G. D. Pol Foundation, YMT College of Physiotherapy, Institutional Area, Belpada Rd, Sector 4, Kharghar, Navi Mumbai, Maharashtra 410210
Raigarh
MAHARASHTRA |
9372916466
sharayoosalve@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Dr. G.D. Pol Foundation YMT College of Physiotherapy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1 Both males and females will be included in the study
2 Age group 40 to 70 years
3 First onset of ischemic middle cerebral artery stroke
4 Onset Duration more than 6 months
5 Ability to stand and walk 10 meters with or without aids independently without supervision
6 MMSE score more than 24
|
|
| ExclusionCriteria |
| Details |
1 No cognitive impairment
2 No orthopedic disorders like spondylolisthesis, rheumatoid arthritis or ankylosing spondylitis involving the cervical region.
3 No other neurological disorders that impede balance such as spinal cord injury, vestibular dysfunctions, cerebellar ataxia, Parkinsons disease,
4 No vestibular symptoms like dizziness, nausea or vomiting
5 No history of Whiplash injury or Cervical Surgery
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Cognition
Cervical Range of motion
Cervical proprioception
Balance |
Baseline assessment on 1st Day
(One Day assessment) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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)
|
16/10/2025 |
| 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="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
|
The present study titled “The relationship between cervical range of motion, cervical proprioception, and balance in patients with chronic stroke – A correlational study” focuses on understanding the association between neck function and postural control in stroke survivors. Stroke is one of the leading neurological disorders that results in long-term disability, commonly causing impairments in motor control, posture, and balance. Among these, balance deficits are particularly disabling in patients with chronic stroke. The cervical spine plays an important role in maintaining posture and balance by providing proprioceptive input and contributing to vestibulocolic reflex control. A reduction in cervical range of motion and impaired cervical proprioception may negatively influence postural stability, yet there is limited evidence exploring this relationship in individuals with chronic stroke. The purpose of this study is to determine whether cervical range of motion, cervical proprioception, and balance are related in patients with chronic stroke. The objectives are to assess cervical range of motion using goniometry, evaluate cervical proprioception through the Cervical Joint Position Error Test, measure balance using the Timed Up and Go Test, and correlate these variables. This correlational study will include 31 patients aged 40 to 70 years with ischemic middle cerebral artery chronic stroke of more than six months duration. The instruments used will be a goniometer, the Cervical Joint Position Error Test, and the Timed Up and Go Test. Data analysis will be performed using the Pearson correlation coefficient or Spearman’s test in case of non-normal data distribution, with a significance level set at p less than 0.05. Clinically, establishing this relationship could provide valuable insights for developing targeted rehabilitation strategies such as cervical exercises to improve balance and reduce the risk of falls in stroke survivors. The null hypothesis states that there will be no significant relationship between cervical range of motion, cervical proprioception, and balance in patients with chronic stroke, while the alternative hypothesis proposes that a significant relationship exists between these factors.
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