Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000138684
Ethics application status
Approved
Date submitted
20/12/2022
Date registered
9/02/2023
Date last updated
9/02/2023
Date data sharing statement initially provided
9/02/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Upper limb rehabilitation in Parkinson’s disease; matching motor learning strategies and the person’s cognitive profile
Scientific title
Upper limb rehabilitation in Parkinson’s disease; matching motor learning strategies- motor imagery and cross education - and the person’s cognitive profile
Secondary ID [1] 308503 0
Nil known
Universal Trial Number (UTN)
U1111-1285-5249
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Parkinson's Disease 328352 0
Condition category
Condition code
Neurological 325391 325391 0 0
Parkinson's disease
Physical Medicine / Rehabilitation 325392 325392 0 0
Occupational therapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention program will be administered twice a week, 45 minute sessions, for 5 weeks by a qualified Occupational Therapist with experience with Parkinson's Disease (PD). both groups (intervention and comparator group) will receive intervention in one-on-one sessions once a week face to face in the Clinic or the patient's home and once a week on zoom from the patient’s home.
intervention description: Motor Imagery intervention- practice of dexterity exercises will be performed after imagining the exercise in the first person. After imagining the movement, the patient will perform the activity with the hand that he was instructed to imagine using. For Activities of Daily Living (ADL) which are unilateral practice will be performed only with the dominant arm – following imagery of the activity. For bilateral ADL’s practice will be performed after imagining the activity. Motor imagery will be performed with the verbal guidance of the Occupational Therapist.
After 3 weeks both groups will be asked to give 2-3 dexterity based activities that are meaningful and difficult for them in daily function, those activities will be integrated into the intervention.
Session attendance will be followed and reported.
Intervention code [1] 324967 0
Rehabilitation
Comparator / control treatment
comparator group: Cross Education intervention - practice of dexterity exercises (e.g. versatile manipulation exercises such as collecting toilet paper etc.) will be performed several times with the unaffected side and only thereafter with the more affected side to facilitate cross education. For ADL’s that are unilateral practice will be performed only with the dominant arm. For ADL’s which are bilateral (e.g. cutting food or buttoning), practice of dexterity exercises mentioned above will precede their practice, after which bilateral ADL’s will be practiced with both hands with dominance and previous patient’s function determining each hand’s function within the activity (e.g. a patient that is accustomed to cutting food with the knife in the right hand and the fork in the left will practice with the same laterality in the intervention).
Control group
Active

Outcomes
Primary outcome [1] 333245 0
The Canadian Occupational Performance measure (COPM) is a semi-structured interview measuring self-perceived performance.
Timepoint [1] 333245 0
Prior to intervention initiation, at intervention end and at a 4 week follow up.
Primary outcome [2] 333246 0
Time of completion of a functional task will be recorded (and videotaped conditioned on the participant’s consent): Taking out 2 coins, 2 bills and a credit card from a wallet and placing them on the table.
Timepoint [2] 333246 0
Prior to intervention initiation, at intervention end and at a 4 week follow up.
Primary outcome [3] 333531 0
Time of completion of a functional task will be recorded (and videotaped conditioned on the participant’s consent): Writing/typing task.
Timepoint [3] 333531 0
Prior to intervention initiation, at intervention end and at a 4 week follow up.
Secondary outcome [1] 416313 0
The dexterity questionnaire (DextQ-36 - revised) : The DextQ-36 - revised is a patient-reported dexterity questionnaire regarding ADL functions that require complex UL function. It is based on the dextQ-24 and approval was attained from the main author to perform an official translation process as well as changes to items.
Timepoint [1] 416313 0
Prior to intervention initiation, at intervention end and at a 4 week follow up.
Secondary outcome [2] 416314 0
The Movement Disorder Society - Unified Parkinson’s Disease Rating Scale (MDS-UPDRS). In this research the ADL section (part II) as well as the upper limb items and the pull test from the MDS-UPDRS motor test (III) will be administered.
Timepoint [2] 416314 0
Prior to intervention initiation, at intervention end and at a 4 week follow up.
Secondary outcome [3] 416315 0
The Coin Rotation Task is a test measuring hand dexterity. The task requires the participant to rotate a U.S. nickel (in Israel will be performed with a 10 agorot coin) through consecutive 1800 turns using the thumb, index and middle fingers, as rapidly as possible for 20 rotations.
Timepoint [3] 416315 0
Prior to intervention initiation, at intervention end and at a 4 week follow up.
Secondary outcome [4] 416316 0
The TATOO is a touchscreen assessment tool that measures hand dexterity abilities (developed by Danial-Saad& Chiari, 2017). It tests intentional movements aimed at touchscreen use such as tapping, swiping, pinching and other motor activities of the hand.
Timepoint [4] 416316 0
Prior to intervention initiation, at intervention end and at a 4 week follow up.
Secondary outcome [5] 416317 0
The Nine Hole Peg Test (NHPT) assesses finger dexterity by measuring the time it takes to insert and remove nine small pegs into a wooden board.
Timepoint [5] 416317 0
Prior to intervention initiation, at intervention end and at a 4 week follow up.

Eligibility
Key inclusion criteria
Inclusion criteria: PD diagnosis of at least two years, Hoehn and Yahr =>2, existence of lateralization determined by the Unified Parkinson’s Disease Rating Scale motor examination and the patient subjective report.
Minimum age
50 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion criteria: existence of other neurological diagnosis (e.g., stroke, dementia).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed- the person who determines if a subject was eligible for inclusion in the trial will be unaware of the allocation- when the decision will be made and to which group the subject will be allocated.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
block randomization with computerised sequence generation and stratification.
Stratification will be according to the UPDRS II score (cut off point 17).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Repeated measure ANOVA mixed design with a within factor (time) and between factor (intervention type) will be used to examine the first aim and Pearson correlations for the second aim (p<.05).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
12/02/2023
Actual
Date of last participant enrolment
Anticipated
15/12/2024
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 25160 0
Israel
State/province [1] 25160 0

Funding & Sponsors
Funding source category [1] 312743 0
University
Name [1] 312743 0
University of Haifa
Country [1] 312743 0
Israel
Primary sponsor type
University
Name
University of Haifa
Address
199 Aba Khoushy Ave. Mount Carmel, Haifa, Israel
Zip code: 3498838
Country
Israel
Secondary sponsor category [1] 314364 0
None
Name [1] 314364 0
Address [1] 314364 0
Country [1] 314364 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312048 0
University of Haifa ethics comittee
Ethics committee address [1] 312048 0
Ethics committee country [1] 312048 0
Israel
Date submitted for ethics approval [1] 312048 0
09/03/2021
Approval date [1] 312048 0
18/04/2021
Ethics approval number [1] 312048 0
121/22

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 123270 0
Miss Rachel Kizony
Address 123270 0
University of Haifa
199 Aba Khoushy Ave. Mount Carmel, Haifa, Israel
Zip code: 3498838
Country 123270 0
Israel
Phone 123270 0
+972 543550898
Fax 123270 0
Email 123270 0
[email protected]
Contact person for public queries
Name 123271 0
Noa Cohen
Address 123271 0
University of Haifa
199 Aba Khoushy Ave. Mount Carmel, Haifa, Israel
Zip code: 3498838
Country 123271 0
Israel
Phone 123271 0
+972 543516048
Fax 123271 0
Email 123271 0
[email protected]
Contact person for scientific queries
Name 123272 0
Noa Cohen
Address 123272 0
University of haifa
199 Aba Khoushy Ave. Mount Carmel, Haifa, Israel
Zip code: 3498838
Country 123272 0
Israel
Phone 123272 0
+972 543516048
Fax 123272 0
Email 123272 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.