| CTRI Number |
CTRI/2017/03/008130 [Registered on: 17/03/2017] Trial Registered Prospectively |
| Last Modified On: |
31/01/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
An observational study to assess the effect of grip strength on functional activities in Parkinson Disease patients. |
|
Scientific Title of Study
|
Effect of grip strength on function in people diagnosed with Parkinsons disease: A cross sectional study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 5104/17 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MS LINCY KURIAN |
| Designation |
Post Graduate Student (MPT) |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Physiotherapy,
Father Muller Medical College,
Kankanady,Manglore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7026643682 |
| Fax |
|
| Email |
lincy7kurian@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Sydney Roshan Rebello |
| Designation |
Assistant Professor |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Physiotherapy,
Father Muller Medical College,
Kankanady,Manglore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
9343569219 |
| Fax |
|
| Email |
sydneypt@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
MS LINCY KURIAN |
| Designation |
Post Graduate Student (MPT) |
| Affiliation |
Father Muller Medical College |
| Address |
Department of Physiotherapy,
Father Muller Medical College,
Kankanady,Manglore
Dakshina Kannada
KARNATAKA
575002
India |
| Phone |
7026643682 |
| Fax |
|
| Email |
lincy7kurian@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Ms Lincy Kurian |
| Address |
Department of Physiotherapy,
Father Muller Medical college,
Kankanady,Mangalore- 575002
Karnataka |
| Type of Sponsor |
Other [Self financing] |
|
|
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 |
| Lincy Kurian |
Father Muller Medical College Hospital |
Department of Physiotherapy,R Ward, 3rd Floor
Dakshina Kannada
KARNATAKA |
7026643682
lincy7kurian@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Father Muller Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Parkinsons Disease, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Jamar Hand Dynamometer
Nine Hole Peg Test
PROFILE –PD
|
1. Jamar Hand Dynamometer: Jamar hand-held dynamometry is valid and useful for determining grip strength. It is recommended to perform three attempts for all strength measurements.
2. Nine Hole Peg Test: Nine Hole Peg Test is used to assess dexterity and upper extremity function. It is a clinically useful test with excellent test-retest reliability. The Nine Hole Peg Test can be easily administered in individuals with neurological conditions.
3. PROFILE –PD: Profile PD is a scale consisting of 24 items that measure the impact of Parkinson Disease (PD) on body system and activities of individual. Profile PD is designed to assess PD specific impairments and activities, through a combination of subjective report and observation.
|
|
|
Inclusion Criteria
|
| Age From |
50.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects with Clinical diagnosis of Parkinson Disease.
2.Subjects belong to Modified Hoehn and Yahr classification of disability, stage 1 to stage 3 Age of 50 years and above.
4.Male and Female
5.Subjects who follow simple instruction.
6.Mini-Mental State Examination score 24 or above.
7.Able to ambulate with or without an assistive device.
|
|
| ExclusionCriteria |
| Details |
1.History of neurological condition other than Parkinson disease
2.Patient with complete auditory or visual loss.
3.Patient who are not co-operative.
4.People with pain and arthritis in the hands |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Jamar Hand Dynamometer
Nine Hole Peg test
Profile PD |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="59"
Sample Size from India="59"
Final Enrollment numbers achieved (Total)= "59"
Final Enrollment numbers achieved (India)="59" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
30/03/2017 |
| Date of Study Completion (India) |
30/03/2018 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
None yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Altered grip strength predicts poor health, functional
impairment and impairment in activities of daily living. Studies conducted on
association of grip strength in severity, duration and disease progression
demonstrated that Parkinson’s severity remained strongly associated with grip
strength. However no study has assessed the effect of grip strength on upper
extremity function and activities of daily living. Hence this study intends to
assess grip strength and functional activities in people diagnosed with
Parkinson’s disease. This study is a cross sectional study, to find the effect
of grip strength on function and activities of daily living in 59 subjects diagnosed with Parkinson’s
disease that will be conducted in Father Muller Medical College Hospital, Mangalore,
Karnataka. The primary outcome measures will be Jamar Hand Dynamometer,Nine
Hole peg test and PROFILE PD.
|