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CTRI Number  CTRI/2026/01/101201 [Registered on: 15/01/2026] Trial Registered Prospectively
Last Modified On: 14/01/2026
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   Impact of Fatigue Awareness and Exercise Program on Fatigue and Quality of Life in Family Caregivers of Children with Cerebral Palsy. 
Scientific Title of Study   Effect of Fatigue Awareness and Therapeutics Program on Chronic Fatigue Syndrome and Quality of Life in Family Caregivers of Children with Cerebral Palsy: 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  Dr Geetanjali Prashant Koli 
Designation  Post Graduate Student in Department of Community Physiotherapy 
Affiliation  Maharashtra Institute of Physiotherapy, Latur 
Address  Maharashtra Institute of Physiotherapy, Latur, MIMSR campus, Ambajogai road, Latur 413531

Latur
MAHARASHTRA
413531
India 
Phone  8291735545  
Fax  02382-227246  
Email  geetanjalikoli611@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sangeetha M 
Designation  Professor and HOD  
Affiliation  Maharashtra Institute of Physiotherapy, Latur 
Address  Maharashtra Institute of Physiotherapy, Latur, MIMSR campus, Ambajogai road, Latur 413531

Latur
MAHARASHTRA
413531
India 
Phone  9842827771  
Fax  02382-227246  
Email  Saisangeetha2621@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Sangeetha M 
Designation  Professor and HOD  
Affiliation  Maharashtra Institute of Physiotherapy, Latur 
Address  Maharashtra Institute of Physiotherapy, Latur, MIMSR campus, Ambajogai road, Latur 413531

Latur
MAHARASHTRA
413531
India 
Phone  9842827771  
Fax  02382-227246  
Email  Saisangeetha2621@gmail.com  
 
Source of Monetary or Material Support  
Department of Community Physiotherapy, Maharashtra Institute of Physiotherapy, Latur, MIMSR campus, Ambajogai road, Latur-413531 
 
Primary Sponsor  
Name  Maharashtra Institute of Physiotherapy, Latur 
Address  Maharashtra Institute of Physiotherapy, Latur, MIMSR campus, Ambajogai road, Latur 413531  
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sangeetha M  Maharashtra Institute of Physiotherapy, Latur  Department of Community Physiotherapy, OPD-G14, Maharashtra Institute of Physiotherapy, Latur, MIMSR campus, Ambajogai road, Latur 413531
Latur
MAHARASHTRA 		 9842827771

Saisangeetha2621@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Caregivers of Cerebral Palsy Children with Chronic Fatigue Syndrome  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Fatigue Awareness and Therapeutics Program  Interventional group Participants will receives Fatigue awareness and education 5 session, one session per week. Intervention will be of 3 sessions weekly for 6 weeks which includes Warm up- 5-10 mins, Static Cycling–10mins, Cool-down- 5-10 mins, Bensons relaxation and Deep Breathing Exercise and Energy Conservation Technique.  
Comparator Agent  Routine care  Control group receives routine caregiving support. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Family caregivers of a children aged 1-12 year diagnosed with CP.
2.Family member who is primarily caring for child with CP.
3.Participants willing to provide written informed consent and commit to the study protocol.
4.Participants who are experiencing moderate to severe fatigue for at least 3 months.
 
 
ExclusionCriteria 
Details  1.Family caregivers with chronic disorders, disabilities and neurological problems were excluded.
2.Participants with any comorbidities like uncontrolled HTN and DM were excluded.
3.Participants with psychological disorders were excluded.
4.Pregnant women caring for CP child.
5.Participants receiving concurrent fatigue management programs or involved in any other physical training program were excluded.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1.Chalder Fatigue Scale
2.Fatigue Severity Scale
3.WHOQOL- BREF
4.Caregivers strain index 		 All outcomes will be assessed at baseline and post intervention that is after 6 weeks. Follow-up will be taken after 4 weeks of post intervention assessment. 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   25/01/2026 
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   This is a Randomized Controlled Trial.
Subjects will be includes according to inclusion and exclusion criteria. The entire procedure involved in the study will be explained to each subject. A written informed consent will be obtained from the participants. Demographic data of the participants will be collected. Patients will be assessed for Chalder Fatigue Scale, Fatigue Severity Scale, WHOQOL- BREF, Caregivers strain index questionnaire pre and post to intervention and follow up will be done 1 month after protocol. Group A will receive Fatigue awareness and education, Physical activity and Energy conservation techniques. Group B will receive routine caregiving support. Interventional group Participants will receives Fatigue awareness and education 5 session, one session per week. 
Intervention will be of 3 sessions weekly for 6 weeks which includes Warm up- 5-10 mins, Static Cycling–10mins, Cool-down- 5-10 mins, Bensons relaxation and Deep Breathing Exercise and Energy Conservation Technique. Control group receives routine caregiving support.
 
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