| CTRI Number |
CTRI/2024/04/065843 [Registered on: 16/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessing Coordination In Aging: Validation Of The Comprehensive Coordination Scale In Healthy Older Adults |
|
Scientific Title of Study
|
Validation Of Comprehensive Coordination Scale In Healthy Older Adults |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riya |
| Designation |
Undergraduate Student |
| Affiliation |
Maharishi Markandeshwar ( Deemed To Be University), MMIPR |
| Address |
Maharishi Markandeshwar ( Deemed To Be University) , MMIPR
(Department Of Physiotherapy)
Mullana
Mullana, Haryana
Ambala
HARYANA
133207
India |
| Phone |
8295123685 |
| Fax |
|
| Email |
riyaindel@134gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akanksha Saxena |
| Designation |
Assistant Professor |
| Affiliation |
Markandeshwar ( Deemed To Be University), MMIPR |
| Address |
Mullana,(Ambala) Maharishi Markandeshwar ( Deemed To Be University), MMIPR (Department Of Physiotherapy)
Mullana, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9958729161 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
Details of Contact Person
Public Query
|
| Name |
Dr Akanksha Saxena |
| Designation |
Assistant Professor |
| Affiliation |
Maharishi Markandeshwar ( Deemed To Be University) , MMIPR |
| Address |
Maharishi Markandeshwar ( Deemed To Be University) , MMIPR (Department Of Physiotherapy), Mullana
Mullana, Haryana
Ambala
HARYANA
133207
India |
| Phone |
9958729161 |
| Fax |
|
| Email |
akankshasaxena623@mmumullana.org |
|
|
Source of Monetary or Material Support
|
| Maharishi Markandeshwar ( Deemed To Be University) , MMIPR (Department Of Physiotherapy) Mullana |
|
|
Primary Sponsor
|
| Name |
self |
| Address |
Department of physiotherapy MMIPR ,Maharishi Markandeshwar (Deemed to be university), Mullana, Ambala |
| Type of Sponsor |
Other [] |
|
|
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 Akanksha Saxena |
Maharishi Markandeshwar Institute of Physiotherapy and Rehabilitation, Department Of Library |
Mullana,Maharishi Markandeshwar ( Deemed To Be University) , MMIPR, Department Of Physiotherapy,
Ambala
HARYANA |
9958729161
riyaindel@134gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the ethics committee (IEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy normal individual, who are able to follow verbal commands |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Participant who are able to follow verbal commands. |
|
| ExclusionCriteria |
| Details |
Any neurological such as epilepsy, ataxia, stroke, non – coordination difficulties, individual with coordination difficulties , With any musculoskeletal condition fracture, pain, radiculopathy ,Participant with any unhealed wound, Involved any psychological condition, Participant with any history of trauma
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Comprehensive coordination scale (CCS), upper extremity functional scale, Lower extremity function scale, Modified Marching in place test, Timed up and Go (TUG) |
15 min |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| upper extremity functional scale, Lower extremity function scale, Modified Marching in place test, Timed up and Go (TUG) |
10 mint |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
10/05/2024 |
| 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="4"
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
|
Our bodies go through a lot of complex changes as we age, which affects how we feel about ourselves overall. Furthermore, disturbances to our balance and coordination are not unusual. Moreover, we may naturally deteriorate in strength, balance, and coordination, which increases our risk of falling. The only instrument available to assess an individual’s capacity for synchronizing their performance and motions is a thorough comprehensive coordination scale. Those who are eligible for the study will be selected as prospective participants. In order to participate in the study, each chosen individual must sign a written informed consent form confirming that they have read the terms of the study .A maximum three to four attempts are allowed for practice, and each test is taken until the participant fully understands the requirements. Both sides of the body are used for every test that evaluates unilateral talents. It is required to do two trials for exams that assess speed and repetitions. While the behavioral components are scored on the second trial, the speed or number of repetitions are measured on the first. Every aspect of conduct is broken down and assigned a distinct score. Furthermore, we are using additional scales for comparison, including the modified marching in place test, the timed up and go test, the lower extremity function scale, and the upper extremity function scale. Each test is demonstrated to the participant once by the examiner. and every test point undergoes independent analysis and scoring. and then collect the data for find out result with aim of validation of comprehensive coordination scale in healthy older adults.
|