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Comparing the effects of Carr & Shepherd approach and mirror therapy on hand motor function among sub-acute stroke patients; a randomized clinical trial

Protocol summary

Study aim
To compare the effects of Carr & Shepherd approach and mirror therapy on hand grasp, precision grip, pinching grip, gross motor function and grip strength among sub-acute stroke patients
Design
Three arm parallel group randomised with blinded outcome assessment.
Settings and conduct
The current study was multi-centered study that included centers of Faisalabad, Punjab, Pakistan. Allied Hospital District Headquarters Hospital Nusrat Abdul Rauf Centre for Enablement
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Both genders within range of 40 years-65 years with first stroke attack at subacute stage, with MMSE scoring > 21 and MAS scoring < 3 Exclusion Criteria: Patients with cognitive impairment, orthopedic deformity, fracture, subluxation, any other co morbidity related to upper limb, history of aphasia, visual impairment, tumor and neurological deficit.
Intervention groups
Group A: participants will receive FES 10 minutes with parameters of; frequency 20-50 Hz, width of pulse 0μs-300μs, peak current at <70 mA, 1s ramp up and down which remained turned on and off for next 5s alternatively. Group B: participants will receive FES same as group A. in combintion with 20 reps of each maneuver of Carr & Shepherd Holding a cup, pen, plate, pouring water from one glass to another, pinching of ball bearing etc. Group C: participants will receive FES with same as group A in combination with mirror therapy with 10 reps of each movement. Flexing and extending the elbow and wrist,ulnar and radial deviation of wrist, making a Thumb-up gesture, empty hand grip, spherical grip, and Opposition with all fingers
Main outcome variables
The outcomes of current study were; Hand Grasp Pinching grip Precision grip Gross Motor Function Grip strength

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230731058992N1
Registration date: 2023-09-11, 1402/06/20
Registration timing: prospective

Last update: 2023-09-11, 1402/06/20
Update count: 0
Registration date
2023-09-11, 1402/06/20
Registrant information
Name
Tayyaba Falak
Name of organization / entity
The University of Faisalabad
Country
Pakistan
Phone
+92 332 0772705
Email address
tayyabafalak14@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-15, 1402/06/24
Expected recruitment end date
2023-10-15, 1402/07/23
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effects of Carr & Shepherd approach and mirror therapy on hand motor function among sub-acute stroke patients; a randomized clinical trial
Public title
Comparing the effects of Carr & Shepherd approach and mirror therapy on hand motor function among sub-acute stroke patients; a randomized clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both male and female genders will be included Patients having age within range of 40 years-65 years The stage of stroke attack was sub-acute Patients had first attack of stroke in their life Patients with Mini Mental State Examination (MMSE) scoring > 21 Patients with Modified Ashworth Scale scoring < 3
Exclusion criteria:
Patients with cognitive impairment Patients with inability of cooperation and follow simple instruction given by instructor Patients with history of orthopaedic deformity, fracture, subluxation, and any other co morbidity related to upper limb Patients with history of aphasia, visual impairment, tumor, and neurological deficit
Age
From 40 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Outcome assessor
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
According to inclusion exclusion criteria, all the enrolled participants would be allocated into three groups randomly by chit and draw method. The randomization process in this study will follow a simple randomization method at the individual level. Unit of randomization would be individual participant, that means each individual participant would be randomly assigned to three groups that are Carr &Shepherd approach group, mirror therapy group and Function electrical stimulation group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The current study will be single blinded, as the outcome assessor should be kept blinded to reduce risk of biasness. Outcome assessors should have no information about the recruitment of participants. As they would not know which participant belongs to Group A, B and C, the risk of biasness will be reduced.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Review Commitee
Street address
University Avenue, Faisal Town Canal Road, Faisalabad.
City
Faisalabad
Postal code
38000
Approval date
2023-08-09, 1402/05/18
Ethics committee reference number
TUF/DR/SA/MSPP/2023/246

Health conditions studied

1

Description of health condition studied
Sub-acute stage of stroke (3 weeks- 6 months)
ICD-10 code
G46.4
ICD-10 code description
Cerebellar stroke syndrome

Primary outcomes

1

Description
Hand Grip Strength
Timepoint
1,3,6 week
Method of measurement
Dynamometers are the cheap, portable and best used device for the measurement of grip strength by using static effort of muscles, having excellent inter rater and intra rater reliability for all the performed movements with ICC ≥ 0.855.

2

Description
Hand Grasp
Timepoint
1,3,6 week
Method of measurement
Action research arm test is reliable tool with the inter-rater reliability of 0.99. The range of ARAT score vary from 0 (no movement) to 57 (maximum movement).

Secondary outcomes

1

Description
Gross Motor Functions
Timepoint
1,3,6 week
Method of measurement
Action research arm test is reliable tool with the inter-rater reliability of 0.99. The range of ARAT score vary from 0 (no movement) to 57 (maximum movement).

2

Description
Grip
Timepoint
1,3,6 week
Method of measurement
Action research arm test is reliable tool with the inter-rater reliability of 0.99. The range of ARAT score vary from 0 (no movement) to 57 (maximum movement).

Intervention groups

1

Description
Intervention group:
Category
Treatment - Devices

2

Description
Intervention group:
Category
Rehabilitation

3

Description
Intervention group:
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Allied Hospital
Full name of responsible person
Dr. Sobia Nawaz
Street address
Jail Road adjacent Faisalabad Medical University, Near Sargodha Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9210082
Email
info@pmc.edu.pk
Web page address
http://www.pmc.edu.pk

2

Recruitment center
Name of recruitment center
Civil Hospital
Full name of responsible person
Dr. Shaista Bano
Street address
Mall Road, Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 41 9200140
Fax
+92 41 9200141
Email
dhqfaisalabad@gmail.com

3

Recruitment center
Name of recruitment center
Nusrat Abdul Rauf Centre for Enablement; NACE
Full name of responsible person
Mr. Imran Saqi
Street address
433-D, Main Boulevard, D-Ground, Peoples Colony
City
Faisalabad
Postal code
38000
Phone
+92 333 7204761
Email
imran.saqi@hotmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Tayyaba Falak
Street address
260 D Peoples Colony No. 1 Faisalabad
City
Faisalabad
Postal code
38000
Phone
+92 332 0772705
Email
tayyabafalak23@gmail.com
Grant name
No
Grant code / Reference number
No
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Self Funded
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Tayyaba Falak
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
260 D Peoples Coony No.1 Faisalabd
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 332 0772705
Email
tayyabafalak14@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Nusrat Abdul Rauf Centre of Enablement
Full name of responsible person
Areesha Jameel
Position
Physiotherapist
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
433-D, Main Boulevard Road, D-Ground, Faisalabad
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 302 6619414
Email
areeshajameel59@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
The University of Faisalabad
Full name of responsible person
Asma
Position
Lecturer
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
709-B people's colony no. 1
City
Faisalabad
Province
Punjab
Postal code
38000
Phone
+92 321 7607141
Email
baigasma96@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is 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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparing the effects of Carr & Shepherd approach and mirror therapy on hand motor function among sub-acute stroke patents; a randomized clinical trial
When the data will become available and for how long
Data will be available for other people almost 6 months after the completion of study.
To whom data/document is available
Data will be available for other people almost 6 months after the completion of study
Under which criteria data/document could be used
The data/document could be used by communicating with the principle investigator Tayyaba Falak gmail : tayyabafalak14@gmail.com
From where data/document is obtainable
Tayyaba Falak Gmail: tayyabafalak14@gmail.com
What processes are involved for a request to access data/document
The data/document could be used by communicating with the principle investigator Tayyaba Falak gmail : tayyabafalak14@gmail.com
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