Protocol summary

Study aim
To determine the effects of mobile application, dexteria fine motor skills on hand dexterity and grip strength in chronic stroke patients.
Design
Randomized controlled trial
Settings and conduct
• Jinnah Hospital Lahore(JHL) • Ittefaq trust hospital Lahore
Participants/Inclusion and exclusion criteria
Inclusion criteria Age: 40 to 60 years both male and female • Six months to 2 years post stroke • Participants must be able to open and close their fingers (even only 2 cm of movement) • Before stroke there must be fully functional hand • Normal or intact vision where as exclusion criteria is • Neurological disorders other than stroke for example multiple sclerosis or Parkinson disease. • Upper extremities acute orthopedic conditions. • Any cardiopulmonary complications • Medically unstable patients.
Intervention groups
Conventional hand therapy group: The control group received conventional hand function rehabilitation therapy including, strengthening exercises which consist of palm down wrist flexion exercise, dexterity( shifting exercise) and fine motor skills(nine peg hole exercise) this protocol is given for 30-60 minutes session with 10 minutes of rest duration, 3 times per week for one month. Dexteria App therapy Group: The experimental group received an additional mobile application therapy including , dexterity fine motor skills, bowling game, scribble game and peglight game in addition to the conventional therapy for hand function. This protocol is given for 30-60 minutes session with 10 minutes of rest duration, 3 times per week for one month.
Main outcome variables
• The Nine Hole Peg Test (NHPT) • Fugl-Meyer Motor assessment (FMA) • The Box & Block Test (BBT) • hand dynamometer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20221104056391N1
Registration date: 2022-11-29, 1401/09/08
Registration timing: registered_while_recruiting

Last update: 2022-11-29, 1401/09/08
Update count: 0
Registration date
2022-11-29, 1401/09/08
Registrant information
Name
Maida Mushtaq
Name of organization / entity
University of management and technology Lahore Pakistan
Country
Pakistan
Phone
+92 306 4738063
Email address
maida.mushtaq@umt.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-02, 1400/09/11
Expected recruitment end date
2022-06-06, 1401/03/16
Actual recruitment start date
2022-08-02, 1401/05/11
Actual recruitment end date
2023-01-02, 1401/10/12
Trial completion date
2023-01-02, 1401/10/12
Scientific title
Effects of mobile application dexteria fine motor skills on hand dexterity and grip strength in chronic stroke patients
Public title
Effects of mobile application dexteria fine motor skills on hand dexterity and grip strength in chronic stroke patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age: 40 to 60 years both male and female Six months to 2 years post stroke Participants must be able to open and close their fingers (even only 2 cm of movement) Before stroke there must be fully functional hand Normal or intact vision
Exclusion criteria:
Neurological disorders other than stroke for example multiple sclerosis or Parkinson disease. Upper extremities acute orthopedic conditions Any cardiopulmonary complications Medically unstable patients
Age
From 40 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 22
Actual sample size reached: 22
Randomization (investigator's opinion)
Randomized
Randomization description
Allocation of patients in both groups will be done through simple random sampling and via lottery method
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is single blinded and participants will not be aware of the group allocation.
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and ethics committee
Street address
Raiwind road lahore
City
Lahore
Postal code
55150
Approval date
2021-12-29, 1400/10/08
Ethics committee reference number
REC/RCR&AHS/21/0255

Health conditions studied

1

Description of health condition studied
STROKE PATIENTS WITH UPPER LIMB IMPAIRMENT OF FINE MOTOR SKILLS AND DEXTERITY
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
FINE MOTOR SKILLS AND DEXTERITY
Timepoint
4 WEEKS AFTER INTERVENTION
Method of measurement
FUGL MEYER ASSESMENT SCALE, BOX AND BLOCK TEST, NINE PEGHOLE TEST

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: This group received an additional mobile application therapy including , dexterity fine motor skills, bowling game, scribble game and peglight game in addition to the conventional therapy for hand function. This protocol is given for 30-60 minutes session with 10 minutes of rest duration, 3 times per week for one month. All the activities were performed in sitting position After four weeks outcome is documented via specified tools including FMA, NHPT, BBT, and grip strength (through dynamometer)
Category
Rehabilitation

2

Description
Control group: The control group received conventional hand function rehabilitation therapy including, strengthening exercises which consist of palm down wrist flexion exercise, dexterity( shifting exercise) and fine motor skills(nine peg hole exercise) this protocol is given for 30-60 minutes session with 10 minutes of rest duration, 3 times per week for one month. All the activities were performed in sitting position After four weeks outcome was documented via specified tools including FMA, NHPT, BBT, and grip strength (through dynamometer)
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
JINNAH HOSPITAL LAHORE
Full name of responsible person
MAIDA MUSHTAQ
Street address
raiwind road lahore
City
lahore
Postal code
55150
Phone
+92 306 4738063
Email
maida.mushtaq@umt.edu.pk

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
University of management and technology lahore
Full name of responsible person
Maida Mushtaq
Street address
Raiwind road lahore
City
Lahore
Postal code
55150
Phone
+92 306 4738063
Email
Maida.mushtaq@umt.edu.pk
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Abc
Proportion provided by this source
1
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
University of management and technology lahore
Full name of responsible person
Maida Mushtaq
Position
Demonstrator
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Raiwind road lahore
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 306 4738063
Email
Maida.mushtaq@umt.edu.pk

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of management and technology lahore
Full name of responsible person
Maida Mushtaq
Position
Demonstrator
Latest degree
Master
Other areas of specialty/work
Rehabilitation management
Street address
Raiwind road lahore
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 306 4738063
Email
Maida.mushtaq@umt.edu.pk

Person responsible for updating data

Contact
Name of organization / entity
University of management and technology lahore
Full name of responsible person
Maida Mushtaq
Position
Demonstrator
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Raiwind road lahore
City
Lahore
Province
Punjab
Postal code
55150
Phone
+92 306 4738063
Email
Maida.mushtaq@umt.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
due to confidentiality
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
effects of mobile application dexteria fine motor skills on hand dexterity and grip strength in chronic stroke patients
When the data will become available and for how long
1/1/2023
To whom data/document is available
only academics
Under which criteria data/document could be used
only academics
From where data/document is obtainable
maida.mushtaq@umt.edu.pk
What processes are involved for a request to access data/document
google drive request
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