FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2023/08/056763 [Registered on: 22/08/2023] Trial Registered Prospectively
Last Modified On: 16/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Physiotherapy (Not Including YOGA) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Exercise decreases tremors and improve hand function in Parkinsons patients 
Scientific Title of Study   Effect of low impact exercises with behavioral relaxation therapy on tremors, upper limb function and disability in patients with Parkinson’s Disease 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  NAGARJUNA NARAYANASETTI 
Designation  Ph.D. Scholar  
Affiliation  Manav Rachna International Institute of Research & Studies 
Address  Q Block, Department of Physiotherapy, Faculty of Allied Health Sciences Sector-43 Surajkund –Delhi Road Faridabad

Faridabad
HARYANA
121001
India 
Phone  9493112741  
Fax    
Email  nag.sri22@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  NAGARJUNA NARAYANASETTI 
Designation  Ph.D. Scholar  
Affiliation  Manav Rachna International Institute of Research & Studies 
Address  Q Block, Department of Physiotherapy, Faculty of Allied Health Sciences Sector-43 Surajkund –Delhi Road Faridabad

Faridabad
HARYANA
121001
India 
Phone  9493112741  
Fax    
Email  nag.sri22@gmail.com  
 
Details of Contact Person
Public Query
 
Name  NAGARJUNA NARAYANASETTI 
Designation  Ph.D. Scholar  
Affiliation  Manav Rachna International Institute of Research & Studies 
Address  Q Block Department of Physiotherapy, Faculty of Allied Health Sciences Sector-43 Surajkund –Delhi Road Faridabad

Faridabad
HARYANA
121001
India 
Phone  9493112741  
Fax    
Email  nag.sri22@gmail.com  
 
Source of Monetary or Material Support  
MANAV RACHNA INTERNATIONAL INSTITUTE OF RESEARCH & STUDIES, Q Block Department of Physiotherapy, Faculty of Allied Health Sciences Sector-43 Surajkund –Delhi Road Faridabad 
 
Primary Sponsor  
Name  Nagarjuna Narayanasetti 
Address  Ph.D. Scholar Department of Physiotherapy Manav Rachna International Institute of Research & Studies, Q Block Department of Physiotherapy, Faculty of Allied Health Sciences Sector-43 Surajkund –Delhi Road Faridabad 
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 
Dr P Jagadeesh  Sri Krishna Neuro and General Hospital  12-3-11, Department of Neurology, Gandhi Nagar Andhra Bank line Ksaibugga
Srikakulam
ANDHRA PRADESH 
9493687640

jagadeeshpondala@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
Research Ethics Committee, MRIIRS  Approved 
Sri Krishna Neuro and General Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: G20||Parkinsons disease,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Conventional Physiotherapy, Relaxation Exercise  Conventional Physiotherapy - • Imitating various upper limb and lower limb free movements by seeing therapist/ video Postural corrections ( observing and identifying improper posture and correcting ) Mat activities i.e. rolling, lying to sitting, sitting to stand, weight shifts, trunk rotations in sitting etc. Stretching : Upper limb, Lower limb and Trunk muscles Teaching turn around : In supine lying position patient is instructed to moving upper limb and lower limbs in opposite directions and in same directions Gait training Frenkal’s exercise Progressive muscle relaxation  
Intervention  Low Impact Exercises, Behavioral Relaxation therapy  Low Impact Exercises :Free movements of shoulder, elbow, wrist, trunk, hip, knee and ankle in sitting or supine lying, Graded Stationary cycling for 30 – 45 min Behavioral Relaxation Technique - Each BRT Session will take 30min approximately including adaptation, training and measurement. Each session is followed by post session assessment by Behavioral Relaxation Scale (BRS) 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Diagnosed as Primary Parkinson’s Disease by Neurologist and fulfilled UK Parkinson’s Disease Society Brain Bank clinical Diagnostic Criteria (Hughes et al., 1992)
Hoehn and Yahr scale Stage III-IV of Parkinson’s with Tremors dominating
•UPDRS III Motor task 21 (Action or Postural tremor of hand) score of 2 or 3 (Mild to moderate
Medically stable and taking prescribed medication
Agrees to participate in the study
 
 
ExclusionCriteria 
Details  Secondary Parkinson’s syndrome, Parkinson’s Plus syndrome patients
With other severe co-morbidities like lung, heart, kidney , liver, dysfunction, or cancer.
Patients with serious mental illness or dementia.
Patients with cognitive impairments.
PD patients without tremors.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Fahn’s Tremor Rating Scale (by blinding of outcome assessor) &
Bain & Findley Tremor ADL Scale
9 Hole peg test
Unified Parkinson’s Disease Rating Scale (UPDRS), Part I – intellectual impairment, Part II – activities of daily living, Part III – motor examination
Behavioral Relaxation Scale (BRS) 
6 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Behavioral Relaxation Scale  After every session  
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   28/08/2023 
Date of Study Completion (India) 27/12/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 27/12/2024 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  
N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Background: The Parkinson’s Disease (PD) is a “complex neurodegenerative disorder, a second most common neurodegenerative disorder next to Alzheimer’s disease caused by deficiency of a neurochemichal ‘Dopamine’ in the nigrostriatum system”. Tremor is a major motor cardinal symptoms in parkinson’s. The current pharmacological treatments carbidopa and levodopa combination, Anticholinergics and surgical interventions deep brain stimulation, Stereotactic thalamotomy are choice of treatment in severe cases and less published evidence on tremors. Clinical findings suggests that tremor increased by stress and usually physiotherapist suggests patients to practice meditation, yoga, breathing exercises and other relaxation techniques to reduce tremor. Objectives: The study will investigate effect of low impact exercises with behavioral relaxation therapy techniques on Parkinson’s tremor. Methodology : It will be a prospective experimental Randomized control study . 30 Hoehn and Yahr scale Stage III-IV Parkinson’s, and tremor dominating patients were randomly allocated into experimental and control group. Pre and post tests will be taken using Fahn’s Tremor rating scale (FTRS) , Bain and Findley Tremor ADL Scale ,9 hole peg test. Interventional Group will receive low impact exercises with Behavioral Relaxation Therapy (BRT) Techniques and Control group will receive conventional physiotherapy protocol and relaxation exercise thrice a week for 5 weeks under supervision of Physiotherapist and follow up after 6 weeks.  

Keywords : Low impact exercises ,Behavioral Relaxation Therapy, Tremor, Upper limb function, Disability, Parkinson’s Disease.

 
Close