"Effects of a Combined Repetitive Transcranial Magnetic Stimulation and Physical Therapy Protocol on Motor Function, Balance, and Quality of Life in Chronic Post-Stroke Hemiplegia: A Case Series"

Chronic post-stroke hemiplegia frequently results in persistent motor deficits, impaired balance, and reduced quality of life. Conventional physical therapy is fundamental for functional recovery; however, motor improvement often plateaus during the chronic phase. Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique that has shown potential to enhance motor recovery by modulating cortical excitability and promoting neuroplasticity.

This case series aims to investigate the effects of a combined protocol of repetitive transcranial magnetic stimulation and conventional physical therapy on motor function, balance, and quality of life in individuals with chronic post-stroke hemiplegia. Participants will undergo rTMS applied to the motor cortex in conjunction with a structured physical therapy program. Clinical outcomes will be assessed before and after the intervention to explore feasibility, safety, and potential functional benefits of the combined approach.

Study Overview

• Status: Not yet recruiting
• Conditions: Chronic Stroke; Balance
• Intervention / Treatment: Device: rTMS; Other: physical therapy

Detailed Description

Chronic post-stroke hemiplegia is associated with persistent motor impairment, balance deficits, and reduced quality of life. Although physical therapy remains the cornerstone of rehabilitation, functional recovery frequently plateaus in the chronic phase. Strategies that enhance neuroplasticity and potentiate the effects of rehabilitation may help optimize long-term outcomes.

Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique capable of modulating cortical excitability within motor networks. When applied to the motor cortex, rTMS may facilitate neuroplastic changes that support motor recovery, particularly when combined with task-oriented physical therapy.

This prospective case series investigates the feasibility, safety, and clinical effects of a combined intervention consisting of repetitive transcranial magnetic stimulation and conventional physical therapy in individuals with chronic post-stroke hemiplegia. Participants meeting predefined eligibility criteria will undergo a protocol integrating rTMS sessions with a structured physical therapy program focused on motor function, balance training, and functional mobility.

Clinical assessments will be conducted before and after completion of the intervention to evaluate changes in motor performance, balance abilities, and health-related quality of life. Safety will be monitored throughout the study, with adverse events recorded and managed in accordance with established guidelines for non-invasive brain stimulation and physical therapy.

This case series is intended to generate preliminary clinical evidence regarding the combined use of rTMS and physical therapy in the chronic post-stroke population and to inform the design of future controlled clinical trials.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: ALBERTO SANCHEZ SIERRA, PhD; Phone Number: 608801238; Email: alberto.sanchez@uclm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of first-ever unilateral ischemic or hemorrhagic stroke confirmed by neuroimaging (CT or MRI)
• Chronic post-stroke hemiplegia (≥ 6 months since stroke onset)
• Moderate to severe motor impairment of the affected lower limb (FMA-LE score between 10 and 28 points)
• Age between 18 and 75 years
• Medically stable and able to participate in a rehabilitation program
• Ability to understand study procedures and provide written informed consent
• No contraindications to repetitive transcranial magnetic stimulation (rTMS), according to current safety guidelines.

Exclusion Criteria:

• History of epilepsy or seizures
• Presence of pacemakers, cochlear implants, intracranial metallic implants, or other contraindications to rTMS
• Severe cognitive impairment or communication deficits preventing participation
• Progressive neurological disorders or unstable medical conditions
• Participation in other experimental neurorehabilitation interventions during the study period
• Any condition judged by investigators to compromise safety or data valid

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: rTMS Group; Participants assigned to this arm received low-frequency repetitive transcranial magnetic stimulation (rTMS) combined with task-specific physical therapy. rTMS was applied over the primary motor cortex (M1) of the unaffected hemisphere at a frequency of 1 Hz and an intensity of 90% of the individual resting motor threshold. Each session delivered 1,200 pulses over 20 minutes. Immediately after each rTMS session, participants underwent a standardized physical therapy session focused on lower-limb strengthening and balance training. This combined intervention was designed to modulate interhemispheric inhibition and facilitate motor recovery in individuals with chronic post-stroke hemiplegia.	Device: rTMS; Repetitive transcranial magnetic stimulation (rTMS) was delivered using low-frequency stimulation applied over the primary motor cortex. Stimulation parameters were individually adjusted based on the resting motor threshold and kept constant across sessions. Coil positioning and stimulation conditions were standardized to ensure reproducibility. Safety screening was conducted prior to stimulation sessions, and adverse events were monitored throughout the intervention period in accordance with established safety guidelines.; Other: physical therapy; The physical therapy intervention consisted of a structured, task-oriented rehabilitation approach targeting motor control, balance, and functional mobility. Exercises were selected to promote activation of the affected limb, postural control, and functional movement patterns. The intervention followed standardized neurorehabilitation principles, with progressive adaptation of tasks based on individual performance and tolerance.
Active Comparator: physical therapy Group; Participants assigned to this arm received a standardized physical therapy program focused on motor recovery, balance training, and functional mobility in chronic post-stroke hemiplegia. The intervention included task-specific exercises targeting the affected lower limb, muscle strengthening, postural control, and balance activities adapted to individual functional capacity. Therapy sessions were designed according to neurorehabilitation principles and progressed based on patient performance and tolerance. This arm served as a reference intervention to describe functional changes associated with conventional physical therapy in the chronic phase of stroke recovery.	Other: physical therapy; The physical therapy intervention consisted of a structured, task-oriented rehabilitation approach targeting motor control, balance, and functional mobility. Exercises were selected to promote activation of the affected limb, postural control, and functional movement patterns. The intervention followed standardized neurorehabilitation principles, with progressive adaptation of tasks based on individual performance and tolerance.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Motor function (FMA)	Motor function was assessed using the Fugl-Meyer Assessment (FMA) for the affected upper and lower limbs. The FMA is a validated and reliable scale for evaluating motor impairment after stroke, with higher scores indicating better motor performance. The FMA has a total score ranging from 0 to 226 points (upper extremity: 0-66; lower extremity: 0-34; with additional domains contributing to the total score), with higher scores indicating better motor function. Changes in FMA scores were used to describe changes in motor function following the combined rTMS and physical therapy intervention.	Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
balance	Balance was assessed using the Berg Balance Scale (BBS), a validated clinical tool designed to evaluate static and dynamic balance performance in individuals after stroke. The BBS consists of 14 functional tasks commonly affected in post-stroke hemiplegia. The BBS has a total score ranging from 0 to 56 points, with higher scores indicating better balance ability. Changes in BBS scores were used to describe balance improvements following the combined rTMS and physical therapy interventio	Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
Functional mobility	Functional mobility was assessed using the Timed Up and Go (TUG) test. The TUG evaluates the ability to stand up from a seated position, walk, turn, and sit down, reflecting functional mobility and dynamic balance in individuals with post-stroke hemiplegia. Lower completion times indicate better functional performance. Changes in TUG time were used to describe improvements in mobility following the combined rTMS and physical therapy intervention.	Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Muscle strength (handgrip strength)	Muscle strength was assessed using handgrip dynamometry. Handgrip strength provides an objective and reliable measure of overall muscle strength and has been associated with functional status in individuals with chronic post-stroke hemiplegia. Changes in handgrip strength were used to descriptively assess strength improvements following the combined rTMS and physical therapy intervention.	Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.
Quality of life SF-36	Health-related quality of life was assessed using the Short Form-36 Health Survey (SF-36), a validated questionnaire evaluating multiple domains of perceived physical and mental health. The SF-36 includes eight domains, each scored from 0 to 100, where higher scores indicate better health-related quality of life. Changes in SF-36 scores were used to describe patient-reported improvements in quality of life following the combined rTMS and physical therapy intervention.	Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.

Collaborators and Investigators

• Sponsor: Sierra Varona SL

Study record dates

Study Major Dates

• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 30, 2026

Study Registration Dates

• First Submitted: May 6, 2026
• First Submitted That Met QC Criteria: May 13, 2026
• First Posted (Actual): May 19, 2026

Study Record Updates

• Last Update Posted (Actual): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 13, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: physical therapy; balance; chronic stroke; motor recovery; repetitive transcraneal magnetic stimulation
• Additional Relevant MeSH Terms: Therapeutics; Rehabilitation; Physical Therapy Modalities
• Other Study ID Numbers: Sierra Varona SL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No