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CTRI Number  CTRI/2024/06/068446 [Registered on: 06/06/2024] Trial Registered Prospectively
Last Modified On: 30/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Impact of art therapy and pertubation on cognitive function and fall prevention in older adults  
Scientific Title of Study   Effects of art therapy with perturbation on cognitive function and prevention of risk of fall in 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  Kamal Joshi 
Designation  Post Graduate Student 
Affiliation  Shri guru ram rai university college of paramedical sciences and allied health sciences 
Address  Shri Mahent Indiresh Hospital Department Of Physiotherapy North Block, Basement

Dehradun
UTTARANCHAL
248001
India 
Phone  7830000357  
Fax    
Email  kcjoshi7007@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Surbhi Thapliyal PT 
Designation  Assistant Professor 
Affiliation  Shri guru ram rai university college of paramedical sciences and allied health sciences 
Address  Shri Mahent Indiresh Hospital Department Of Physiotherapy North Block, Basement

Dehradun
UTTARANCHAL
248001
India 
Phone  8979082369  
Fax    
Email  surbhithapliyal.pt@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Surbhi Thapliyal PT 
Designation  Assistant Professor 
Affiliation  Shri guru ram rai university college of paramedical sciences and allied health sciences 
Address  Shri Mahent Indiresh Hospital Department Of Physiotherapy North Block, Basement

Dehradun
UTTARANCHAL
248001
India 
Phone  8979082369  
Fax    
Email  surbhithapliyal.pt@gmail.com  
 
Source of Monetary or Material Support  
Shri Guru Rai University,School of Paramedical And Allied Health Sciences, Pathribagh, Dehradun ,248001  
 
Primary Sponsor  
Name  Kamal Joshi 
Address  Shri Guru Ram Rai University, School of Paramedical And Allied Health Sciences, Pathribagh, Dehradun, 248001 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Kamal Joshi   Department of Physiotherapy.  Shri Mahant Indresh Hospital,Department of Physiotherapy North Block Basement Room No-14 Dehradun
Dehradun
UTTARANCHAL 		 7830000357

kcjoshi7007@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) SHRI GURU RAM RAI INSTITUTE OF MEDICAL AND HEALTH SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G998||Other specified disorders of nervous system in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Pertubation  It is a reactive balance training. Duration of session - 30 mintutes 4 days a week for 5 weeks. Incorporate dynamic movements into traditional balance exercises, such as performing squats or lunges on an unstable surface like a balance board or bosu ball. 
Comparator Agent  Pertubation And Art Therapy   Perturbation-based balance training With Art therapy Art therapy- Tasks included drawing common objects, such as clocks,houses, and trees, as well as self-portraits or drawings of family members. Other tasks included drawing figures after viewing pictures of houses or portraits, finding hidden or different figures in a drawing, drawing with a three-point perspective. Incorporate dynamic movements into traditional balance exercises, such as performing squats or lunges on an unstable surface like a balance board or bosu ball. Treatment duration of session - 60 mintutes 4 days a week for 5 weeks.  
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Age 60–90 years
Both genders
Eligible to participate in the study if they had experienced a fall in the previous three months, had therefore visited the hospital outpatient clinic, and were able to walk without a walking aid for ≥ 15 min.
 
 
ExclusionCriteria 
Details  Diagnosis of any disease or disorder that may affect the safety of training (e.g. osteoporosis, recent fracture or severe contusion of the lower extremities, back or shoulders, or severe cardiopulmonary disease
Also excluded if they were unable to follow instructions due to cognitive problems, unable to provide written informed consent or to communicate.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Mini-BESTest
Mini-Balance evaluation systems test 		 1st day , 14th day, 28th day, 35th day 
 
Secondary Outcome  
Outcome  TimePoints 
MOCA
Montreal Cognitive Asessment  		 1st day , 14th day, 28th day, 35th day 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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 2 
Date of First Enrollment (India)   11/06/2024 
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 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   There is a significant amount of research on perturbation-based balance training for fall prevention in older-adults. Another issue observed in older adults is cognitive function impairment and there is a correlation between cognitive impairments and balance, mild cognitive impairments, an earlier stage of dementia, is associated with poor gait function. Furthermore, subjects who have a decline in both cognitive and motor abilities have a higher risk of fall. Art therapy has shown potential in improving cognitive function which could, in turn, contribute to enhanced  balance (faster). Hence, no study has been done till yet on art therapy with perturbation-based balance training. 
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