Effectiveness of mirror visual feedback therapy combined with home dexterity program as compared to home dexterity program in improving hand function of patients with Parkinson's disease
To compare the effect of Mirror Visual feedback therapy combined with a home dexterity program and home dexterity program in improving hand function of patients with Parkinson's Disease
Design
Two arms Parallel group, single-blind, randomized controlled trial
Settings and conduct
• The study will be conducted in Neurology department Fauji Foundation Hospital.
• Patient will be included in study after taking full informed consent.
• Participants will be screened thoroughly for any exclusion, before getting enrolled.
• Severity of disease will be determined by means of the MDS Unified Parkinson Disease Rating Scale, Part III: Motor (MDS-UPDRS III).
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
All patients with stages 1to 3 in Hoehn and Yahr and who would be on a stable medication regimen.
Patients with impaired hand dexterity
Exclusion Criteria:
1. Patients with history of other neurological conditions,
2. deep brain stimulation,
3. Patients cognitive status < 24,
4. Patients with visual field defects, which will prevent the patient to see their reflection of hand
5. Patients with severe orthopedic conditions of upper limb
Intervention groups
The intervention group (Mirror visual feedback therapy combined with home dexterity program group) will receive Mirror visual feedback therapy combined with home based dexterity Program for 1 hour 3 times a week for 6 weeks. A patient will have to perform six various types of exercises, either bi-manually or unimanually, Both hands will have to be trained equally. The control group (Home dexterity program group) will receive only home dexterity program for 1 hour 3 times a week for 6 weeks
Main outcome variables
Independent Variable:
• Mirror Therapy combined with Home based dexterity program
• Home dexterity program
Dependent Variables:
• Hand function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210615051585N5
Registration date:2022-05-07, 1401/02/17
Registration timing:registered_while_recruiting
Last update:2022-05-07, 1401/02/17
Update count:0
Registration date
2022-05-07, 1401/02/17
Registrant information
Name
Saima Gul
Name of organization / entity
Shifa Tameer - e - Millat University
Country
Pakistan
Phone
+92 51 8441751
Email address
saimagul.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-21, 1401/01/01
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of mirror visual feedback therapy combined with home dexterity program as compared to home dexterity program in improving hand function of patients with Parkinson's disease
Public title
Effect of Mirror therapy and home dexterity program in improving hand function of Parkinson's patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with stages 1to 3 on Hoehn and Yahr scale and who would be on a stable medication regimen
Patients with impaired hand dexterity
Exclusion criteria:
Patients with history of other neurological conditions,
Deep brain stimulation,
Patients cognitive status < 24
Patients with visual field defects, which will prevent the patient to see their reflection of hand
Patients with severe orthopedic conditions of upper limb.
Age
From 50 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment was used for treatment using a sealed envelope. For that, 30 sheets of aluminum paper are properly cut. This paper should be double the size of the paper. 15 Sheets of Carbon paper cut into appropriate size according to the paper used. A standard-sized square paper was taken in which group "(Mirror visual feedback therapy combined with home dexterity program)" was marked. In this way, 15 papers were prepared marked with "(Mirror visual feedback therapy combined with home dexterity program)" and 15 square-shaped papers marked with "(Home dexterity program)". The sheet of paper on which either (Mirror visual feedback therapy combined with home dexterity program) or (Home dexterity program) was marked was folded to fit the envelope. A sheet of Carbon paper was placed on the top of the folded paper (marked either (Mirror visual feedback therapy combined with home dexterity program) or (Home Dexterity Program) facing the envelope. Then the sheet of Aluminum foil was wrapped on the carbon paper (with folded paper inside). All the above prepared were placed in the envelope (which was completely opaque), the envelope was then sealed. In this way 15 envelops of "(Mirror visual feedback therapy combined with home dexterity program)" and 15 envelops of "(Home Dexterity Program)" were prepared with a total number of 30 envelopes. These 30 envelopes were then thoroughly shuffled like a deck of cards. The envelopes were then marked with numbers 1-30. Each participant picked the envelope in order from 1-30 and was given an intervention (Mirror visual feedback therapy combined with home dexterity program or Home Dexterity program) accordingly.
Blinding (investigator's opinion)
Single blinded
Blinding description
Only the researcher doing the study knows which treatment or intervention the participant is receiving. It makes results less likely to be biased. For that, they received an additional device that is not connected and they feel they are receiving treatment apart from their actual treatment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional Review Board and Ethics Committee (IRB and EC) Shifa International Hospital.
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Postal code
25000
Approval date
2021-06-28, 1400/04/07
Ethics committee reference number
IRB#488-21
Health conditions studied
1
Description of health condition studied
Parkinson's patients with impaired hand dexterity
ICD-10 code
G-20
ICD-10 code description
Idiopathic Parkinsonism or Parkinson's disease
Primary outcomes
1
Description
Hand dexterity
Timepoint
Baseline measurement and end of treatment
Method of measurement
Chedoke Arm and Hand Inventory
Secondary outcomes
1
Description
Hand strength
Timepoint
Baseline after intervention
Method of measurement
Hand held dynamometer
2
Description
Reduced rate of tremors
Timepoint
Baseline after intervention
Method of measurement
Clinical rating scale for tremor
3
Description
Hand dominance
Timepoint
Baseline after intervention
Method of measurement
Edinburgh handedness inventory
Intervention groups
1
Description
Mirror visual feedback therapy combined with home dexterity program group: This group will receive Mirror visual feedback therapy combined with a home-based dexterity Program for 1 hour 3 times a week for 6 weeks. A patient will have to perform six various types of exercises, either bi-manually or unimanual. Both hands will have to be trained equally. A mirror box will be used for the performance of Manual dexterity. A plastic foldable triangular box with an attached mirror on a side will be kept on a table so one of the hands of the subject will be reflected by the mirror and another hand will be hidden by the box from the view of the subject. The box will be open from the ends so that the subject can insert their hands into it. The hand which is more affected will be asked to hide behind the mirror.
Category
Rehabilitation
2
Description
Home dexterity program group: This group will perform the same exercises in the home dexterity program but without a mirror box. This protocol will be for 1 hour 3 times a week for 6 weeks. In this group, patients will perform these exercises either bi-manually or unimanual. Both hands have to be trained equally.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Neurology department Fauji Foundation hospital Rawalpindi
Full name of responsible person
Fakhra Khadim
Street address
Fauji Foundaion Hospital Rawalpindi
City
Rawalpindi
Postal code
45730
Phone
+92 331 5932044
Email
fakhrakhadim_dpt48@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Postal code
44000
Phone
+92 51 8441751
Fax
+92 51 8441751
Email
saimagul.ahs@stmu.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shifa Tameer e Millat University
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Province
Punjab
Postal code
44000
Phone
+92 51 8441751
Email
saimaa.gul@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Province
Punjab
Postal code
44000
Phone
+92 51 8441751
Email
saimagul.ahs@stmu.edu.pk
Person responsible for updating data
Contact
Name of organization / entity
Shifa Tameer e Millat University
Full name of responsible person
Dr Saima Gul
Position
Associate Professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Department of Rehabilitation Sciences, Dar ul Shifa Campus, Shifa Tameer e Millat University
City
Islamabad
Province
Punjab
Postal code
44000
Phone
+92 51 8441751
Email
saimagul.ahs@stmu.edu.pk
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD