Effects of SBMT Combined With NMES on UL Functions in Post Stroke Patients

NCT07576465 | Recruiting

• 1 other identifier: REC/RCR&AHS/25/0237
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this study to evaluate the effects of synergy-based motor therapy combined with neuromuscular electric stimulation on upper limb function on post stroke patients

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

• Fugl-Meyer Assesssment _Upper Extremity

  The Fugl-Meyer Assessment for Upper Extremity (FMA-UE) is a standardized tool used to evaluate motor function in the upper limb of post-stroke patients. It assesses movement, coordination, and reflex activity of the shoulder, elbow, forearm, wrist, and hand. The scale includes 33 items, scored on a 3-point scale (0 = cannot perform, 1 = performs partially, 2 = performs fully), with a maximum score of 66 indicating normal function. It helps classify the severity of motor impairment: scores between 0-22 suggest severe, 23-44 moderate, and 45-66 mild impairment. The FMA-UE is based on Brunnstrom's stages of motor recovery and is widely recognized for its high validity and excellent reliability, with inter-rater and intra-rater reliability scores above 0.95. It is considered one of the most reliable clinical tools for evaluating motor recovery in stroke rehabilitation

  8th week

Secondary Outcomes (1)

• Modified Ashworth Scale (MAS)

  8th week

Study Arms (2)

Synergy-based motor therapy and NMES

EXPERIMENTAL

Participants will receive synergy-based motor therapy combined with neuromuscular electrical stimulation (NMES) for upper limb rehabilitation following stroke. Treatment will focus on improving motor control, functional movement, and muscle activation.

Behavioral: Synergy-based motor therapy; Device: Neuromuscular electrical stimulation; Other: Conventional therapy

Conventional therapy

ACTIVE COMPARATOR

Participants will receive conventional physiotherapy for upper limb rehabilitation following stroke, including standard exercises aimed at improving strength, range of motion, and functional ability.

Behavioral: Synergy-based motor therapy; Device: Neuromuscular electrical stimulation; Other: Conventional therapy

Interventions

Synergy-based motor therapy BEHAVIORAL

First do the 5 minutes warm up exercises(passive range of motion exercises for shoulder,elbow ,wrist and then synergy based motor therapy for 25 minutes in which the flexor synergy facilitation ( 10 rep,3 sets) and brushing and tapping for sensory cueing and then 5 minutes of cool down exercises(slow passive movements of upper limb)

Conventional therapy; Synergy-based motor therapy and NMES

Neuromuscular electrical stimulation DEVICE

NMES applied to wrist extensors .Frequency: 35Hz ,Pulse Width250 ,Duty cycle :10s on /20s off ,Duration : 25 minutes

Conventional therapy; Synergy-based motor therapy and NMES

Conventional therapy OTHER

The conventional therapy group will receive standard physiotherapy for the upper limb for 30-45 minutes per session, five days per week for 6-8 weeks. It will include gentle warm-up, range of motion exercises, light strengthening, and simple functional activities like reaching, grasping, and daily task practice. Each session will end with stretching and relaxation. This treatment aims to improve movement, strength, and function without using NMES or synergy-based training.

Conventional therapy; Synergy-based motor therapy and NMES

Eligibility Criteria

• Age: 50 Months - 65 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \) Age :50 to 65 2) Both male and female 3) Ischemic Stroke onset among 3 to 6 months (sub-acute section) 4) Hemiplegia affected upper limb 5) The score of Modified ash worth scale rating \<2 for upper limb 6) The score of Mini mental state score \>25

You may not qualify if:

• \) Recurrent stroke or bilateral involvement 2) Cognitive or conversation impairment 3) Presence of pacemaker or contraindications to NMES 4) Uncontrolled comorbid situation (e.g extreme cardiac diseases )

Sponsors & Collaborators

• Riphah International University: lead

Study Sites (1)

District Head Quarter Hospital , Jhang

Jhang, Punjab Province, 35200, Pakistan

RECRUITING

Related Publications (8)

• Wang C, Peng L, Hou ZG, Li J, Zhang T, Zhao J. Quantitative Assessment of Upper-Limb Motor Function for Post-Stroke Rehabilitation Based on Motor Synergy Analysis and Multi-Modality Fusion. IEEE Trans Neural Syst Rehabil Eng. 2020 Apr;28(4):943-952. doi: 10.1109/TNSRE.2020.2978273. Epub 2020 Mar 4.

  PMID: 32149692 BACKGROUND

• Zhou HX, Hu J, Yun RS, Zhao ZZ, Lai MH, Sun LH, Luo KL. Synergy-based functional electrical stimulation and robotic-assisted for retraining reach-to-grasp in stroke: a study protocol for a randomized controlled trial. BMC Neurol. 2023 Sep 12;23(1):324. doi: 10.1186/s12883-023-03369-2.

  PMID: 37700225 BACKGROUND

• Niu CM, Chou CH, Bao Y, Wang T, Gu L, Zhang X, Cui L, Xuan Z, Zhuang C, Li S, Chen Z, Lan N, Xie Q. A pilot study of synergy-based FES for upper-extremity poststroke rehabilitation. Neurosci Lett. 2022 May 29;780:136621. doi: 10.1016/j.neulet.2022.136621. Epub 2022 Apr 5.

  PMID: 35395324 BACKGROUND

• Wang T, Bao Y, Hao H, Zhang X, Li S, Xie Q, Lan N, Niu CM. Customization of Synergy-Based FES for Post-Stroke Rehabilitation of Upper-Limb Motor Functions. Annu Int Conf IEEE Eng Med Biol Soc. 2018 Jul;2018:3541-3544. doi: 10.1109/EMBC.2018.8513083.

  PMID: 30441143 BACKGROUND

• Sorimachi Y, Akaida H, Kutsuzawa K, Owaki D, Hayashibe M. Synergy-Based Evaluation of Hand Motor Function in Object Handling Using Virtual and Mixed Realities. Sensors (Basel). 2025 Mar 26;25(7):2080. doi: 10.3390/s25072080.

  PMID: 40218597 BACKGROUND

• Niu CM, Bao Y, Zhuang C, Li S, Wang T, Cui L, Xie Q, Lan N. Synergy-Based FES for Post-Stroke Rehabilitation of Upper-Limb Motor Functions. IEEE Trans Neural Syst Rehabil Eng. 2019 Feb;27(2):256-264. doi: 10.1109/TNSRE.2019.2891004.

  PMID: 30763238 BACKGROUND

• Pandian S, Arya KN, Kumar V, Joshi AK. Synergy-Based Motor Therapy Inducing Favorable Changes in Motor Function Components among Poststroke Subjects: A Single-Group Study. J Neurosci Rural Pract. 2022 Mar 8;13(2):261-269. doi: 10.1055/s-0042-1743458. eCollection 2022 Apr.

  PMID: 35694074 BACKGROUND

• Bolognini N, Russo C, Edwards DJ. The sensory side of post-stroke motor rehabilitation. Restor Neurol Neurosci. 2016 Apr 11;34(4):571-86. doi: 10.3233/RNN-150606.

  PMID: 27080070 BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• Aruba Saeed

  Riphah International University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Imran Amjad

CONTACT

03324390125; imran.amjad@riphah.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomized for RCT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)