A pilot randomized controlled trial investigating the effects of soft robotic-assisted hand training on upper limb function, lung function, and quality of life in stroke survivors undergoing rehabilitation

This study utilized the Soft Robotic Glove from Maitland, China, to address symptoms in stroke patients, including spasms, hand weakness, and paralysis. The glove is designed for rehabilitation and enhances various hand functions while stimulating brain nerves for improved functionality. Pinch training involves opposing each finger individually, while mirror training uses the healthy hand to lead the affected side fingers in synchronized actions. Fine motor training utilizes a power glove to drive each affected finger to perform extension and flexion exercises, while functional training simulates daily activities that require hand grip, such as gripping a water bottle. Enhanced Soft Robotic Assisted Hand Training Protocol A Pilot Randomized Controlled Trial (RCT) will be conducted to evaluate the feasibility of Soft Robotic-Assisted Hand Training with Standard Therapy (SRAHT-ST) on the upper limb function, lung function, and quality of life of stroke survivors, as compared to Standard Therapy alone (ST). Recruitment will be from the Petaling Jaya community, with assessments and treatments at Dewan Community Desa Mentari, Petaling Jaya. Two experienced physiotherapists (researchers and research assistants) with more than five years of experience and degree holders will conduct the study. The researcher will conduct the assessments such as screening, baseline assessments, implementing interventions, and evaluating study outcomes. The duration is one-hour treatment sessions, three times per week for eight weeks (24 sessions), under the supervision of physiotherapists. The program will also incorporate the Graded Repetitive Arm Supplementary Program (GRASP). This study program focuses on graded and repetitive exercises to enhance neuroplasticity and motor skills in the affected arm, including reaching, grasping, and object manipulation. The program comprises five sections: Stretching, Arm Strengthening, Hand Strengthening, Coordination, and Hand Skills. These sections include six key exercise components: Range of motion, Strengthening, Repetitions of the stroke-affected arm and hand, Weight-bearing, Trunk control, and Repetitions using both arms. Participants will be given logbooks and GRASP guidelines as a home exercise program (Katy, 2023). The assessments will be measured at baseline, 4-week, and 8-week follow-ups. 1. Experimental Group: SRAHT Combined Standard therapy ( ST ) The experimental group will perform task-specific training using a soft robotic glove with GRASP. In 60-minute sessions, participants will perform 20 minutes of hand-functional tasks using a soft robotic glove, and 40 minutes of GRASP exercises. A researcher will monitor sessions for proper execution and intensity. Participants will engage in home exercise programs (HEP) aligned with GRASP guidelines. Task performing with Soft Robotic Glove (SRAHT ) 1. The Box and Block Test (BBT): Participants will grasp 2.5 cm x 2.5 cm wooden blocks from a box of 150 within 1 minute, lifting and crossing the 15.2 cm barrier at their midline and releasing the box using a soft robotic glove (mirror mode). Participants will be given 5 minutes to practice the task before being evaluated. 2. Water bottle task: Participants will hold an empty plastic water bottle (diameter: 76mm) using a soft robotic glove (mirror mode) for 5-10 minutes. A 5-minute practice precedes the water bottle task. 3. Fork grasping tasks: Participants will lift and manipulate a fork using a soft robotic glove with mirror mode for 5-10 minutes. A 5-minute practice precedes the fork-grasping tasks. 4. Pen grasping tasks: Participants will lift and manipulate a pen using a soft robotic glove with mirror mode for 5-10 minutes. A 5-minute practice precedes the pen-grasping tasks. The Graded Repetitive Arm Supplementary Programme (GRASP)- Standard therapy SECTION 1: STRETCHING The first section of exercises is to help warm up your upper extremities. 1. Total arm stretch 10 counts 2 repetition 2. Shoulder shrug 3 counts 10 repetitions 3. The twist right and left three counts five repetitions 4. Hand and wrist stretch 3 counts 5 repetitions SECTION 2: INCREASING ARM STRENGTH The exercises are focused on increasing arm strength 1. Push up (Count for 3) 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 2. One arm push-up (Count for 3) 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 3. Chairs up (Count for 3) 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 4. Shoulder exercise: arm to the front (Count for 3) 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 5. Shoulder exercise: arm to side (Count for 3) 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 6. Elbow exercise (Count for 3) 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 7. Wrist Exercise Part 1 (Count for 3) 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 8. Wrist exercise part 2 (Count for 3) 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions SECTION 3: HAND STRENGTHENING The exercise focuses on increasing the strength of the hand. 13. Grip power (Count for 3) 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 14. Finger power 1. Place the putty on the table and roll it into a thick rope. Take each finger of your weaker hand, starting with your thumb, and push into the putty. 2. After you finish all five fingers, re-roll the putty with your weaker hand. 3. Do this whole sequence five times. 15. Finger twist 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 16. Finger strength 1. Roll the putty into a ball with a weaker hand. 2. Hold the putty ball in your stronger hand. 3. Take one finger at a time of your weaker hand, start with your thumb, and push it into the putty ball. 4. Do not hyperextend the finger – don’t bend the finger backwards. 5. Repeat the sequence ten times. 17. Cutting Repeat 5 times Repeat 10 times SECTION 4: COORDINATION The exercises will focus on increasing coordination and the ability to do your day-to-day activities. 18. Waiter-cup (20 times) Repeat 3 times Repeat 2 times (as fast as you can) 19. Advanced waiter (20 times) Repeat the whole sequence 3 times. 20. Pouring Pour back and forth 20 times 21. Rolling ball with a partner Catches the ball 20 times. 22. Rolling ball with no partner Catches the ball 20 times. 23. Drop and catch the ball Repeat 20 times. Switch and drop the ball with the weaker hand 20 times. 24. Total arms stretch SECTION 5: HAND SKILLS (The exercise is to help improve hand skills). 25. Laundry Repeat 5 times. 26. Button T-shirt 1. Take a shirt with buttons out of your closet. 2. Put it on and push up all the buttons. 3. Now undo the buttons. Repeat 5 times. 27. Hang up the cloth 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 28. Lego 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 29. Picks up sticks 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 30. Paper clip chain 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 31. Poker Chips 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 32. Open the jar 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions 33. Drying off 2 sets of 8 repetitions 2 sets of 10 repetitions 3 sets of 10 repetitions Group Size 1 hour session for face-to-face group training will be divided into 2 groups: The experiment is 5 participants, and the control group is 5 participants. • Experimental Treatment Group: 5 participants for the first hour. • Control Treatment Group: 5 participants for the second hour. Strategies for assessing and monitoring adherence to the intervention include: 1. Attendance Tracking: Utilize checklists to track client attendance at each session. Conduct follow-ups after sessions to identify and address any challenges hindering adherence. 2. Appointment Reminders: Send reminders one day before sessions. 3. Preparation and Punctuality: Encourage participants to arrive 15 minutes early to prepare mentally and physically. Call participants running late by more than 15 minutes to avoid disruptions. 4. Cancellation Management: Promptly reschedule canceled sessions to prevent treatment gaps. 5. Supervised Intervention: A researcher supervises the intervention to ensure correct execution and required intensity. 6. Home Exercise Programs (HEP): Implement HEP aligned with GRASP guidelines for both groups to encourage adherence outside supervised sessions. 7. Performance Evaluation: Evaluate adherence to intervention guidelines using performance assessment methods at 0, four weeks, and eight weeks. 8. Feedback and Monitoring: Regular communication channels with participants for feedback and progress monitoring. Address challenges promptly to maintain overall adherence to program requirements and goals. -Ask the participant and family if there are any issues with the exercises (query if too easy, too hard, query pain) -Check to see if the log sheets are done. Discuss barriers and potential solutions if exercise compliance is low (< 45 min daily). Level of Intensity and Assessment: The duration of one training session is 60 minutes with low intensity to ensure safety and proper exercise technique. Borg RPE is used to assess participants' perceived exertion.