"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"

NCT07597746 | Not Yet Recruiting

• 1 other identifier: Sierra Varona SL
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Balance; Chronic Stroke

Keywords

repetitive transcraneal magnetic stimulation; chronic stroke; motor recovery; balance; physical therapy

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Muscle strength (handgrip strength)

  Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.

• Quality of life SF-36

  Baseline (pre-intervention), immediately after completion of the intervention (2 weeks), and at 1-month follow-up.

Study Arms (2)

rTMS Group

EXPERIMENTAL

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; Other: physical therapy

physical therapy Group

ACTIVE COMPARATOR

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

Interventions

rTMS DEVICE

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.

rTMS Group

physical therapy OTHER

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.

physical therapy Group; rTMS Group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Sierra Varona SL: lead

MeSH Terms

Interventions

Physical Therapy Modalities

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

ALBERTO SANCHEZ SIERRA, PhD

CONTACT

608801238; alberto.sanchez@uclm.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Blinding was implemented at the outcome assessment and data analysis levels. Outcome assessors responsible for administering clinical and functional tests were not involved in the intervention delivery and were unaware of group allocation. Data were anonymized and coded prior to statistical analysis, and the statistician conducted all analyses using masked group labels. Due to the nature of the transcranial stimulation intervention, care providers delivering the treatment and study investigators were not blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized parallel-group interventional study in which patients with stroke were allocated to either transcranial stimulation plus conventional rehabilitation or conventional rehabilitation alone. Participants remained in their assigned group throughout the study, with no crossover between intervention arms.

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 19, 2026
• Study Start (Estimated): June 5, 2026
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: May 19, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share