NCT07578779

Brief Summary

To determine the combined effects of frenkel's exercises and electrical muscle stimulation on coordination, balance and proprioception in stroke patients.

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable stroke

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable stroke

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress4%
May 2026Aug 2026

First Submitted

Initial submission to the registry

May 5, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 11, 2026

Completed
9 days until next milestone

Study Start

First participant enrolled

May 20, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2026

Last Updated

May 11, 2026

Status Verified

May 1, 2026

Enrollment Period

1 month

First QC Date

May 5, 2026

Last Update Submit

May 5, 2026

Conditions

Keywords

BalanceCoordinationEMSIschemiaProprioceptionRehabilitationStroke

Outcome Measures

Primary Outcomes (3)

  • The Berg Balance Scale (BBS)

    It's a 14-item performance-based measure, meaning it assesses how well a person can perform specific tasks related to balance. Each item is scored on a 5-point scale (0-4), with higher scores indicating better balance, and a total score range of 0-56.

    Baseline and 8th week

  • The Nottingham Sensory Assessment (NSA)

    NSA is used to evaluate sensory impairments, particularly in individuals who have experienced stroke. scores ranging from 0 (extreme difficulty/unable to perform) to 4 (no difficulty) for each item.

    baseline and 8th week

  • The Lower Extremity Motor Coordination Test (LEMOCOT)

    (LEMOCOT) scoring scale involves assessing an individual's ability to perform specific lower extremity movements, with scores ranging from 0 (extreme difficulty/unable to perform) to 4 (no difficulty) for each item. The total score is obtained by summing the scores of all items, with a higher score indicating better motor coordination.

    Baseline and 8th Week

Study Arms (2)

Frenkels exercise with EMS

EXPERIMENTAL

Participant will receive EMS for 10 minutes and Frenkels exercise for 20 minutes for 3 days per week for 8 weeks

Other: Frenkels exercise with EMS

Conservative Treatment

ACTIVE COMPARATOR

Participants will receive routine therapy for 30 minutes. It could be hot pack, IR with routine exercises for 3 days per week for 8 weeks.

Other: Conservative treatment

Interventions

Group A will include 19 participants. Each participant will receive EMS for 10 minutes and Frenkels exercise for 20 minutes for 3 days per week for 8 weeks In Week 1-2 we will apply 50 Hz EMS pulse duration of 150 μs, intermittent with 5 s of EMS stimulation to perform the movement and 10 s of rest stimulation for adaptation while focusing lower limb exercises in according to frenkles exercises for 20 min in lying position Week 3-4: 60 Hz EMS stimulation will be applied pulse duration of 200 μs, intermittent with 5 s of EMS stimulation to perform the movement and 10 s of rest with frenkles exercises in sitting position Week 5-6 Frequency of 70 Hz pulse duration of 250 μs, intermittent with 5 s of EMS stimulation to perform the movement and 10 s of rest EMS stimulation will be applied with frenkles exercises in standing position Week 7-8: In progression, Frequency of 85 Hz and pulse duration of 300 μs, intermittent with 5 s of EMS stimulation to perform the movement and 10 s of rest

Frenkels exercise with EMS

Group B will also include 19 participants. Each participant will receive routine therapy for 30 minutes. It could be hot pack, IR with routine exercises for 3 days per week for 8 weeks. Weeks 1-2: Initial Phase 1. Breathing exercises 2. Range of motion exercises 3. Seated exercises Weeks 3-4: Strengthening Phase Resistance band exercises: Upper and lower limb strengthening b) Weight-bearing exercises c) Gait training: Walking with support d) Balance exercises: Weeks 5-6 Functional Phase 1. Functional activities: Reaching, scooting, transferring 2. Gait training: Walking without support, navigating obstacles 3. Balance exercises: Dynamic balance, reaction training 4. Strengthening exercises: Weeks 7-8: Advanced Phase 1. Advanced gait training: Stair climbing, curbs, uneven surfaces 2. Complex functional activities: Cooking, dressing, household chores

Conservative Treatment

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Typically 50-65 years old.(14)
  • Both male and female are included
  • Patients with subacute ischemic stroke (hemiplegia).(15)
  • Ability to walk independently for at least 10minutes.(16)
  • Diagnosis of a first-time stroke or without sequel of a previous stroke(15)
  • MOCA score\>26 to confirm adequate cognitive function.
  • Brunnstrom exercise recovery stages of 3-4 or higher(17)
  • Voluntarily provided informed consent prior to participating

You may not qualify if:

  • Patients with severe cognitive impairment or dementia.(16)
  • Patients with unstable medical conditions, such as uncontrolled hypertension or cardiac disease.
  • Patients with recent surgery or injury that may affect participation in the study.
  • Patients with contraindications to electrical muscle stimulation (EMS), such as unstable cardiopulmonary medical conditions pacemakers or metal implants

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (6)

  • 1. Ko EJ, Chun MH, Kim D-Y, Kang Y, Lee SJ, Yi JH, et al. Frenkel's exercise on lower limb sensation and balance in subacute ischemic stroke patients with impaired proprioception. Neurology Asia. 2018;23(3).

    BACKGROUND
  • Shoeb M, Mishra A, Yadav KK, Kumar S, Yadav S. Effect of BAPS Board Versus Frenkel Exercise on Balance in Stroke Patient's-A Pilot Study.

    BACKGROUND
  • Yoo HJ, Park S, Oh S, Kang M, Seo Y, Kim BG, Lee SH. Effects of electrical muscle stimulation on core muscle activation and physical performance in non-athletic adults: A randomized controlled trial. Medicine (Baltimore). 2023 Jan 27;102(4):e32765. doi: 10.1097/MD.0000000000032765.

    PMID: 36705372BACKGROUND
  • Haque S. Effectiveness of frankel exercise to improve balance and function after stroke: Bangladesh Health Professions Institute, Faculty of Medicine, the University …; 2023.

    BACKGROUND
  • Khan S, Shahid W, Khalid R, Pervez M, Hameed R, Khaliq S. Effects of Proprioceptive Neuromuscular Facilitation with and without Electrical Muscle Stimulation on spasticity, gait and lower limb function in chronic stroke patients. Journal of Health and Rehabilitation Research. 2024;4(3):1-6.

    BACKGROUND
  • Arif A, Arshad K, Tariq S, Sundas S, Tariq N, Kabir A, et al. COMPARATIVE EFFECTS OF VIRTUAL REALITY AND FRENKEL'S EXERCISES ON BALANCE, GAIT AND QUALITY OF LIFE IN PATIENTS WITH STROKE. Insights-Journal of Health and Rehabilitation. 2024;2(2 (Health & Rehab)):459-67.

    BACKGROUND

MeSH Terms

Conditions

StrokeIschemia

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Sabiha Arshad

    Riphah International University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 5, 2026

First Posted

May 11, 2026

Study Start

May 20, 2026

Primary Completion (Estimated)

June 20, 2026

Study Completion (Estimated)

August 1, 2026

Last Updated

May 11, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share