Combined Effects of Soft Robotic Hand and Electrical Stimulation on Hand Function in Stroke Survivors

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-65
SponsorLahore University of Biological and Applied Sciences

About this trial

Stroke is a clinically delineated syndrome, which is characterised by an acute, focal neurological deficit resulting from vascular injury (infarction or haemorrhage) within the central nervous system. Notably, around 80 percent of stroke survivors experience post-stroke deficits in upper extremity (UE) motor performance, impacting grip strength, dexterity, and functional independence, which greatly hinder the ability of stroke patients to carry out activities of daily living (ADL), and in turn affects their overall quality of life (QOL).One potential solution to these difficulties is the creation of rehabilitation robotic devices that incorporate hand technology and electrical stimulation. Although soft robotic assistive devices and electrical stimulation have each shown positive effects on motor recovery, their combined use has yet to be thoroughly investigated. This study intends to determine if the simultaneous application of these therapies can speed up rehabilitation results in comparison to independent therapies. Stroke Participants will be divided into two groups, Experimental group and Control group. Both the groups will receive intervention for 40 min/day, 03 days/week, for 08 week and measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosed with their first episode of stroke.

Participants with 3-6 months post stroke.

Participants with normal cognition on Montreal Cognitive Assessment (MOCA) ≥24.

Participants with the ability to extend Metacarpophalangeal (MCP) and Proximal Interphalangeal (PIP) joint to 180 degree passively

Disqualifiers

Presence of other neurological, neuromuscular, orthopedic diseases, or

conditions that may interfere with task performance.

Participants with sensory disturbances in the fingers

Trial design

Design model

Parallel

Treatments tested in this trial

  • Soft Robotic Hand combined with Neuromuscular Electrical Stimulation along with Task Oriented Training

    Other intervention

    Group-1, will follow a rehabilitation program that combines soft robotic hand support, electrical muscle stimulation (EMS), and task oriented training. After the adjustment of soft robotic hand, EMS electrodes will be placed on specific muscles, with set FITT principal as, A pulse frequency of 20 to 50 Hz and a pulse duration of 400 μs will be set with the intensity as per tolerated by the participant. Participants will perform task oriented activities that will include, Reaching to grasp objects, Picking up and releasing things at different heights using active finger and wrist extension. Opening a jar, or bottle, Turning a key or doorknob, Holding and lifting a tray or flat object, Pushing objects forward (like sliding a book across) with the assistance of soft robotic hand while electrical simulations are being delivered through the EMS for 40 min/day, 03 days/week, for 08 week. Measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment.

  • Neuromuscular Electrical Stimulation along with Task Oriented Training

    Other intervention

    The control group will follow a rehabilitation program that combines support of electrical stimulation, and task oriented training. For the stimulation of muscles ComfyStim EMS device will be used. The FITT principal used for EMS will be as, A pulse frequency of 20 to 50 Hz and a pulse duration of 400 μs will be set with the intensity as per tolerated by the participant. Participants will perform task oriented activities that will include, Reaching to grasp objects, Picking up and releasing things at different heights using active finger and wrist extension. Opening a jar or bottle, Turning a key or doorknob, Holding and lifting a tray or flat object, Pushing objects forward (like sliding a book across) while electrical simulations are being delivered through the EMS for 40 min/day, 03 days/week, for 08 week. Measurements will be taken prior to the treatment, after 4 weeks of treatment and 8 weeks post-treatment.

Treatment groups

64 Participants
are divided into 2 treatment groups
Group A: Experimental: Group-1 (Soft Robotic Hand + Neuromuscular Electrical Stimulation)Experimental treatment 1 intervention
Group B: Control: Group-2 ( Neuromuscular Electrical Stimulation)Other 1 intervention

Trial outcomes

Primary outcomes

1

Wolf Motor Function Test

Motor hand function will be assessed using the Wolf Motor Function Test (WMFT). The WMFT evaluates functional ability and movement speed through 17 tasks, including 15 timed functional tasks and 2 strength-based tasks. Each task is scored on a 6-point scale (0-5), with higher scores indicating better performance; total scores range from 0 to 85.

Time frame
Measurements will be taken before the treatment as baseline, after 4 weeks of treatment, and 8 weeks post-treatment
2

Fugl-meyer assessment of upper limb (FMA-UE)

Motor hand function will be assessed using the Fugl-Meyer Assessment of Upper Extremity (FMA-UE). The FMA-UE has demonstrated excellent test-retest and inter- and intra-rater reliability, and evidence for its content validity. The FMA assesses motor recovery in the upper extremity using a 33-item scale scored from 0 to 2 per item, with a maximum score of 66.

Time frame
Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
3

Nine-Peg Hole Test

Dexterity of the affected hand will be assessed using the Nine-Hole Peg Test (NHPT), a standardized and widely used tool for measuring fine motor coordination. Participants are instructed to place nine pegs into nine holes on a board and then remove them as quickly as possible, using one hand at a time. The total time taken to complete the task is recorded in seconds. Shorter completion times indicate better manual dexterity.

Time frame
Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment
4

Dynamometer

Grip strength will be assessed using a hand-held dynamometer, a reliable tool for measuring isometric muscle force. Participants will be instructed to squeeze the device with maximum effort while seated, with the elbow flexed at 90 degrees and the forearm in a neutral position. Each hand will be tested three times, and the highest value will be recorded. This method provides an objective measure of hand strength and is commonly used in stroke rehabilitation to monitor functional recovery and response to intervention.

Time frame
Measurements will be taken before the treatment, after 4 weeks of treatment, and 8 weeks post-treatment

Secondary outcomes

Other outcomes

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