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IRCT20211022052835N6 IRCT 2022-03-29 Shifa Tameer-e-Millat University Comparison of Robotic Hand Therapy and Mirror Therapy in Motor Hand Recovery in Chronic Stroke Patients Comparison of Robotic Hand Therapy and Mirror Therapy in Motor Hand Recovery in Chronic Stroke Patients 2022-04-01 anticipated 34 Complete https://irct.ir/trial/62533 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: N/A, 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 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. N/A Right hemispheric stroke, at least 6 months post stroke , mild to moderate upper extremity impairment and mild to severe hand impairment.. Intervention 1: 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. Intervention 2: 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. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Fouzia Batool
Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad
Islamabad Pakistan 44000 +92 332 7120385 fouzia_dpt.ahs@stmu.edu.pk Shifa Tameer-e-Millat University scientific Fouzia Batool
Pitras Bukhari Road, Shifa Tameer-e-Millat University, H-8/4, Islamabad
Islamabad Pakistan 44000 +92 332 7120385 fouzia_dpt.ahs@stmu.edu.pk Shifa Tameer-e-Millat University Pakistan 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) 40 years 85 years Both Previous cerebrovascular disease Cognitive dysfunction to an extent that would interfere with therapy participation Contracture formation in affected extremity G81.92 Hemiplegia, unspecified affecting left dominant side Rehabilitation Rehabilitation 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. 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. 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. 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. Shifa Tameer-e-Millat University Approved 2022-02-02 Institutional review board and ethical committee and ethical committee of shifa tameer-e-millat univ Pitras Bukhari Road, Shifa international hospital Ltd. sector h-8/4 Islamabad Islamabad Islamabad Capital Territory Pakistan