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

NCT07282938 | Recruiting DMC

• 1 other identifier: UBAS/ERB/FoRS/25/040 Amna
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke; Cerebro-vascular Accident

Keywords

Stroke; hand impairments; soft robotic hand; electrical stimulation; robotic therapy; Cerebrovascular accident

Outcome Measures

Primary Outcomes (5)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• Modified Ashworth Scale

  The Modified Ashworth Scale (MAS) will be used to evaluate muscle spasticity in the affected upper limb. This scale grades resistance during passive soft-tissue stretching on a 6-point ordinal scale (0 to 4, with an additional 1+ grade), where higher scores indicate increased muscle tone. MAS is widely used in stroke rehabilitation to monitor changes in spasticity and assess the effectiveness of interventions aimed at promoting motor recovery.

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

Study Arms (2)

Experimental: Group-1 (Soft Robotic Hand + Neuromuscular Electrical Stimulation)

EXPERIMENTAL

The experimental group will follow a rehabilitation program that combines soft robotic hand support along with electrical muscle stimulation (EMS), and perform task oriented training. Syrebo Hand rehabilitation robotic glove will be used which help the patient to flex and extend the fingers as in open or close a fist and for the stimulation of muscles ComfyStim EMS device will be used, By placing EMS electrodes on the important muscle groups used for gripping, moving the wrist, and making small movements, adjusting the intensity to what each person can handle. After the careful set up of both devices patient will perform task training such as grip-release cycles, reaching to grab objects, pinching small items, and mimicking daily activities like lifting a cup or stacking blocks.

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

Control: Group-2 ( Neuromuscular Electrical Stimulation)

OTHER

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, by placing EMS electrodes on the important muscle groups used for gripping, moving the wrist, and making small movements, adjusting the intensity to what each person can handle. After the careful set up of EMS device patient will perform task training such as grip-release cycles, reaching to grab objects, pinching small items, and mimicking daily activities like lifting a cup or stacking blocks.

Other: Neuromuscular Electrical Stimulation along with Task Oriented Training

Interventions

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

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.

Also known as: Soft Robotic Hand, robotic assisted therapy, electrical stimulation, soft robotic hand and electrical stimulation, task oriented training

Experimental: Group-1 (Soft Robotic Hand + Neuromuscular Electrical Stimulation)

Neuromuscular Electrical Stimulation along with Task Oriented Training OTHER

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.

Also known as: Electrical stimulation, Neuromuscular electrical stimulation, task oriented training

Control: Group-2 ( Neuromuscular Electrical Stimulation)

Eligibility Criteria

• Age: 45 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Modified Ashworth Scale \< 2.
• Participants with the score of 10 to 16 on National Institute of Health Stroke Scale Score (NIHSS Score).

You may not qualify if:

• Presence of other neurological, neuromuscular, orthopedic diseases, or
• conditions that may interfere with task performance.
• Participants with sensory disturbances in the fingers

Sponsors & Collaborators

• Lahore University of Biological and Applied Sciences: lead

Study Sites (2)

Pakistan Society for the Rehabilitation of the Disabled (PSRD)

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

Shadman Medical Center, Stroke Rehabilitation

Lahore, Punjab Province, 54660, Pakistan

RECRUITING

Related Publications (8)

• Kristensen MGH, Busk H, Wienecke T. Neuromuscular Electrical Stimulation Improves Activities of Daily Living Post Stroke: A Systematic Review and Meta-analysis. Arch Rehabil Res Clin Transl. 2021 Nov 12;4(1):100167. doi: 10.1016/j.arrct.2021.100167. eCollection 2022 Mar.

  PMID: 35282150 BACKGROUND

• Ko MJ, Chuang YC, Ou-Yang LJ, Cheng YY, Tsai YL, Lee YC. The Application of Soft Robotic Gloves in Stroke Patients: A Systematic Review and Meta-Analysis of Randomized Controlled Trials. Brain Sci. 2023 Jun 2;13(6):900. doi: 10.3390/brainsci13060900.

  PMID: 37371378 BACKGROUND

• Bayindir O, Akyuz G, Sekban N. The effect of adding robot-assisted hand rehabilitation to conventional rehabilitation program following stroke: A randomized-controlled study. Turk J Phys Med Rehabil. 2022 Jun 1;68(2):254-261. doi: 10.5606/tftrd.2022.8705. eCollection 2022 Jun.

  PMID: 35989963 BACKGROUND

• Chen P, Liu TW, Tse MMY, Lai CKY, Tsoh J, Ng SSM. The Predictive Role of Hand Section of Fugl-Meyer Assessment and Motor Activity Log in Action Research Arm Test in People With Stroke. Front Neurol. 2022 Jul 7;13:926130. doi: 10.3389/fneur.2022.926130. eCollection 2022.

  PMID: 35873769 BACKGROUND

• Chien WT, Chong YY, Tse MK, Chien CW, Cheng HY. Robot-assisted therapy for upper-limb rehabilitation in subacute stroke patients: A systematic review and meta-analysis. Brain Behav. 2020 Aug;10(8):e01742. doi: 10.1002/brb3.1742. Epub 2020 Jun 26.

  PMID: 32592282 BACKGROUND

• Lindsay LR, Thompson DA, O'Dell MW. Updated Approach to Stroke Rehabilitation. Med Clin North Am. 2020 Mar;104(2):199-211. doi: 10.1016/j.mcna.2019.11.002.

  PMID: 32035564 BACKGROUND

• Mosconi MG, Paciaroni M. Treatments in Ischemic Stroke: Current and Future. Eur Neurol. 2022;85(5):349-366. doi: 10.1159/000525822. Epub 2022 Aug 2.

  PMID: 35917794 BACKGROUND

• Murphy SJ, Werring DJ. Stroke: causes and clinical features. Medicine (Abingdon). 2020 Sep;48(9):561-566. doi: 10.1016/j.mpmed.2020.06.002. Epub 2020 Aug 6.

  PMID: 32837228 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Electric Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Physical Stimulation; Investigative Techniques

Study Officials

• Aruba Saeed, PhD

  Lahore University of Biological and Applied sciences, UBAS

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amna Naveed, DPT

CONTACT

+923178731632; amnanaveed14082000@gmail.com

Aruba Saeed, PhD

CONTACT

+923344399403; arubasaeedpt@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Double blinded study approach will be utilized. Participants and outcome assessor both will be blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: After recruitment, the participants will be allocated into their respective groups utilizing the online randomizer tool.

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 15, 2025
• Study Start: December 8, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)