| 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
|
|
|
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
|
|
|
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 systemâ€. 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. |