1.To determine the effect of hand functional recovery through robotic hand training.
2.To compare the effects of robotic hand training and mirror therapy in regaining hand mobility.
Design
Randomized Control Trial (RCT) Single blind study. Study groups: (Mirror Therapy) and (Robotic Hand Therapy) group Phase: N.A Sample size : 34 Randomization: In this study simple random sampling technique is used by sealed envelop method through a computerized random number generator. The study is single blinded as participants is not aware of the intervention group they are placed in. Study center: Single center study
Settings and conduct
National Institute of Rehabilitation Medicine Islamabad. Physiotherapy department. In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The study is single blinded as participants is not aware of the intervention group they are placed in.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: All participants age 40-85 years suffered from a single right hemisphere ischemic or hemorrhagic stroke and were at least 6 months post stroke at time of their enrollment into study. All participants demonstrated mild to moderate upper extremity impairment as defined by Upper extremity fugl-meyer score (range 34-62) and mild to severe hand impairments as defined by the box and block test (range of 1-55).Exclusion criteria will include previous cerebrovascular disease, cognitive dysfunction to an extent that would interfere with therapy participation and any contracture formation in affected extremity.
Intervention groups
There are 2 experimental group 1. Experimental group (A) Robotic Hand Therapy group and 2) Experimental group (B) Mirror Therapy group.
Main outcome variables
Motor Assessment Scale, Upper extremity fugl-meyer Scale, Box and Block Test, Self structured Questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211022052835N6
Registration date:2022-03-29, 1401/01/09
Registration timing:prospective
Last update:2022-03-29, 1401/01/09
Update count:0
Registration date
2022-03-29, 1401/01/09
Registrant information
Name
Fouzia Batool
Name of organization / entity
Shifa Tameer-e-Millat University
Country
Pakistan
Phone
+92 51 8441752
Email address
fouzia_dpt.ahs@stmu.edu.pk
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-04-01, 1401/01/12
Expected recruitment end date
2022-05-31, 1401/03/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Robotic Hand Therapy and Mirror Therapy in Motor Hand Recovery in Chronic Stroke Patients
Public title
Comparison of Robotic Hand Therapy and Mirror Therapy in Motor Hand Recovery in Chronic Stroke Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age 40-85 years
Single right hemispheric ischemic or hemorrhagic stroke
At least 6 months post stroke at time of their enrollment into study
Mild to moderate upper extremity impairment as defined by Upper Extremity Fugl-Meyer score (range 34-62)
Mild to severe hand impairments as defined by the Box and Block test (range of 1-55)
Exclusion criteria:
Previous cerebrovascular disease
Cognitive dysfunction to an extent that would interfere with therapy participation
Contracture formation in affected extremity
Age
From 40 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Care provider
Sample size
Target sample size:
34
Randomization (investigator's opinion)
Randomized
Randomization description
In this study simple random sampling technique is used by sealed envelop method by using a computerized random number generator. The sequence of random allocation is done by an individual who has not directly involved in the study. Random numbers is written on index cards and placed in thick and opaque sealed envelops before the study.After taking consent from the participants for their participation in the study, the therapist opens the envelop and give the respective protocol to the individual. The study is single blinded as participants is not aware of the intervention group they are placed in.Participants will be placed either in to the experimental group 1 (Robotic Hand Therapy) or experimental group 2 (Mirror Therapy) keeping the process completely randomized ,sealed envelope method will be used.
Blinding (investigator's opinion)
Single blinded
Blinding description
Prior to collecting data, participants would be informed about both the treatment techniques used in both groups; experimental group A (Robotic Hand Therapy) and experimental group B (Mirror Therapy). Further they are informed that you will get one of these treatment depending upon the group written on the card inside the envelop you choose. The group A or B belongs to which way of treatment is known to therapist but the patient doesn't know about it.
Placebo
Not used
Assignment
Parallel
Other design features
N/A
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Institutional review board and ethical committee and ethical committee of shifa tameer-e-millat univ
Street address
Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad
City
Islamabad
Postal code
44000
Approval date
2022-02-02, 1400/11/13
Ethics committee reference number
IRB#278-21
Health conditions studied
1
Description of health condition studied
Right hemispheric stroke, at least 6 months post stroke , mild to moderate upper extremity impairment and mild to severe hand impairment.
ICD-10 code
G81.92
ICD-10 code description
Hemiplegia, unspecified affecting left dominant side
Primary outcomes
1
Description
To determine the effect of hand functional recovery through robotic hand training.
Timepoint
Pre intervention at 0-week, and Post Intervention data after 6 weeks will be taken.
Method of measurement
Motor Assessment Scale, Box and Block Test
Secondary outcomes
1
Description
To compare the effects of robotic hand training and mirror therapy in regaining hand mobility.
Timepoint
Pre Intervention at 0 week, and Post Intervention data after 6 weeks will be taken.
Method of measurement
Upper Extremity Fugl Meyer Scale
Intervention groups
1
Description
Intervention Group A: Group A would receive Robotic Hand Therapy along with conventional therapy.There would be 3 sessions per week for minimum 6 weeks. Session would be comprised of 60 minutes.Conventional therapy for left side upper extremity of total 30 minutes included sustained stretching exercises of Elbow Flexors, Pronators,Wrist Flexors and Finger Flexors, PNF techniques (D1 Flexion ,D2 Flexion, D1 Extension, D2 Extension Patterns), Active Assisted and Active Range of motion exercises, Weight bearing on affected upper extremity,Manual mobilizations, and Compression on joints(Shoulder, elbow, wrist and hand).Robotic Hand Therapy: 30 minutes,3 sets,12-15 repetitions, Robotic therapy would be delivered by syrebo robotic hand rehabilitation device.There are 2 modes used in training which includes innovative mirror therapy and task oriented training.In mirror training mode synchronized flexion and extension movement of hand. In task oriented ,with help of robot patient practice grasping and releasing(cylindrical grasp,spherical grasp,hook grasp),staking cups,positioning the cup upright,carrying blocks,putting a ball and drinking water.
Category
Rehabilitation
2
Description
Intervention Group B would receive mirror therapy along with conventional therapy.There would be 3 sessions per week for minimum 6 weeks. Session would be comprised of 60 minutes.Conventional therapy for left side upper extremity of total 30 minutes included sustained stretching exercises of Elbow Flexors, Pronators,Wrist Flexors and Finger Flexors, PNF techniques (D1 Flexion ,D2 Flexion, D1 Extension, D2 Extension Patterns), Active Assisted and Active Range of motion exercises, Weight bearing on affected upper extremity,Manual mobilizations, and Compression on joints(Shoulder, elbow, wrist and hand).In Mirror therapy , a mirror will be positioned between the two arms.The reflecting side of the mirror was adjusted to the non-affected arm. Patients would be move both arms while looking in the mirror.The affected arm should be moved as well as possible, it would take 30 minutes,3 sets,12-15 repetitions included Hand flexion and extension, grasping and releasing(cylindrical grasp,spherical grasp,hook grasp),staking cups,positioning the cup upright,carrying blocks,putting a ball and drinking water.