Effect of robot assisted rehabilitation versus bimanual training on hand motor functions in individuals with chronic stroke

TITLE: EFFECTS OF ROBOT-ASSISTED REHABILITATION VERSUS BIMANUAL TRAINING ON HAND MOTOR FUNCTIONS IN INDIVIDUALS WITH CHRONIC STROKE.

 BACKGROUND

Stroke is a cerebrovascular accident in which there is the sudden loss of neurological function caused by interruption of the blood flow characterized by impairments of sensory, motor, cognitive, perceptual and language functions that leads to combination of muscle weakness, poor dexterity, in-coordination which impairs the performance of activities of daily living (ADLs). Hand function accounted for most of the delicate movements in daily activities, and its deficits seriously influence their performance.

Robot-assisted rehabilitation and Bimanual Therapy are the two promising interventions that have been shown to improve upper arm and hand functions in individuals with various neurological disorders, but their combined effectiveness has not been explored yet. Hence, this research aims to find their effectiveness on the motor functions of the hand in individuals with stroke.

OBJECTIVES

1. To evaluate the effects of robot-assisted rehabilitation versus bimanual training on hand motor functions assessed by the Fugl-Meyer Assessment scale (FMA-UE-Wrist and Hand) in chronic stroke patients.

2. To evaluate the effects of robot-assisted rehabilitation versus bimanual training on the gross and fine motor skills of the hand assessed by the Purdue Pegboard Test in chronic stroke patients.

3. To evaluate the effects of robot-assisted rehabilitation versus bimanual training on the activities of daily living and functional independence assessed by the Functional Independence Measure (FIM) in chronic stroke patients.

4. To evaluate the effects of robot-assisted rehabilitation versus bimanual training on the muscle activities of the hand assessed by Electromyography (EMG) in chronic stroke patients.

HYPOTHESIS:

NULL HYPOTHESIS-

HN1: There is no difference between the effects of robot-assisted hand rehabilitation and bimanual training on hand motor functions in chronic stroke patients.

HN2: There is no difference between the effects of robot-assisted hand rehabilitation and bimanual training on the gross and fine motor skills of the hand in chronic stroke patients.

HN3: There is no difference between the effects of robot-assisted hand rehabilitation and bimanual training on the activities of daily living and functional independence in chronic stroke patients.

HN4: There is no difference between the effects of robot-assisted hand rehabilitation and bimanual training on the muscle activities of the hand in chronic stroke patients.

 ALTERNATE HYPOTHESIS-

HA1: There is a significant difference between the effects of robot-assisted hand rehabilitation and bimanual training hand motor functions in chronic stroke patients.

HA2: There is a significant difference between the effects of robot-assisted hand rehabilitation and bimanual training on the gross and fine motor skills of the hand in chronic stroke patients.

HA3: There is a significant difference between the effects of robot-assisted hand rehabilitation and bimanual training on the activities of daily living and functional independence in chronic stroke patients.

HA4: There is a significant difference between the effects of robot-assisted hand rehabilitation and bimanual training on the muscle activities of the hand in chronic stroke patients.

MATERIALS AND METHODS

STUDY DESIGN: Experimental study design

SAMPLE SIZE:24(12 in each group)

(Outcome measure used is FMA)

Meng G, Meng X, Tan Y, Yu J, Jin A, Zhao Y and Liu X (2018) Short-term Efficacy of Hand-Arm Bimanual Intensive Training on Upper Arm Function in Acute Stroke Patients: A Randomized Controlled Trial. Front. Neurol. 8:726. doi: 10.3389/fneur.2017.00726

ENROLMENT PERIOD: 6-7 months after RRC and IEC clearance

INCLUSION CRITERIA

 

1. Stroke at least 6 months before the beginning of the intervention.
2. Patients who are 50–80 years of age.
3. 50 > FMA score>20
4. Ability to understand simple commands (Mini Mental State Examination score >21).
5. Ability to differentiate sensation on one finger from the other fingers.
6. Give informed consent.

 EXCLUSION CRITERIA

 

1. Recurrent stroke.
2. Other neurological, neuromuscular, and orthopedic diseases.
3. Shoulder or arm contracture/pain.
4. Epilepsy.
5. Visual impairments, hemi-spatial neglect (will be assessed using the line bisection test).

TOTAL STUDY DURATION: 4 weeks intervention duration.

 STUDY PROCEDURES: Patients will be screened based on inclusion and exclusion criteria. They will be enrolled into 2 groups with the help of random allocation software. (Experimental Group 1) will receive Robot-assisted hand rehabilitation and conventional physiotherapy for 5 times a week for 4 weeks. (Experimental Group 2) will receive Bimanual therapy along with conventional physiotherapy for the same duration.

 ASSESSMENT TOOLS: Pre- and post-intervention tests will be carried out using-

·       Fugl-Meyer Assessment – UE for determining motor functions.

·       Purdue Pegboard Test to evaluate gross and fine motor skills.

·       Functional Independence Measure to evaluate the ability to perform activities of daily living.

·       Electromyography – Maximum Voluntary Contraction and Root Mean Square values for Abductor Pollicis Brevis and Extensor Digitorum muscles, for determining the muscle activity of the hand.

 STATISTICAL ANALYSIS PLAN (SAP):

·       Descriptive statistics will calculate the mean and standard deviation for quantitative variables (e.g. age, FIM score) and frequencies for categorical variables (e.g., gender).

·       The Shapiro-Wilk test will assess normality.

·       If the data is normally distributed, an independent t-test will evaluate differences between the groups.

·       Paired t-test will be used to evaluate average difference within the group for normal data.

·       For skewed data, the Wilcoxon signed-rank test will assess within-group changes, and the Mann-Whitney U test will compare between-group differences.

·       Data will be analysed using SPSS 21with Excel for data management.

·       Statistical significance will be set at a 5% alpha level.