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Completed

NCT Number: NCT07512492

Combination Effect of Proprioceptive Training and Transcranial Magnetic Stimulation on Selected Gait Kinematic Parameters in Stroke Patients

this study was done to investigate the Combination effect of proprioceptive training and transcranial magnetic stimulation on selected gait kinematic parameters in stroke patients.

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Key information

Conditions

Transcranial Magnetic Stimulation Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Gait Disorders, Neurologic Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Proprioceptive Training Signs and Symptoms Stroke Vascular Diseases

Age range

50 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

the Qasr El Eyni Hospitals and Private clinics.

Cairo, Egypt

About this study

After a stroke, mobility is influenced by the central nervous system and peripheral neuromuscular and sensory systems. Effective standing and walking require managing body support against gravity and generating propulsion. Gait deficits in stroke survivors often arise from neural, sensory, muscular issues, and coordination problems, leading to movement disorders like spasticity and ataxia that hinder motor control and gait performance. Typically, stroke patients display reduced gait velocity and abnormal kinematics, marked by asymmetries and decreased weight bearing on the affected limb. Research indicates that combining high-frequency Transcranial magnetic stimulation with task-oriented mirror therapy enhances motor function more effectively than Transcranial magnetic stimulation alone, yielding improvements in hand function and cortical excitability. Similar findings for subacute stroke patients highlight the benefits of integrating action observation with Transcranial magnetic stimulation for better upper limb function.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Thirty patients with stroke from both sexes.

  • Age will range from 50 to 60 years old.
  • Duration of stroke ≥ 6 months.
  • Spasticity of the lower limb ranges from 1+ to 2 according to modified ashworth scale
  • The patients able to walk with or without assistive device.
  • Body mass index is less than 30 kg/m2.
  • Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental State Examination scale >24).

Exclusion criteria

  • Previous history of any other neurological disorder
  • Recurrent stroke.
  • Vestibular deficits.
  • Cognitive impairment (a score less than 24 according to mini mental state examination).

5- Cardiac pacemaker

6- Metallic Implants.

7- Aphasia, deafness or blindness

  • Deformities or contractures of the lower limbs

Treatment and study plan

Transcranial Magnetic Stimulation

Device

Transcranial Magnetic Stimulation (TMS) is a non-invasive method that uses magnetic fields to stimulate brain nerve cells through figure-eight or circular coils with strengths of 1.5 to 3.0 Tesla. The TMS pulses, lasting about 100 microseconds, can be adjusted to induce excitatory or inhibitory responses, with a focus on specific brain regions. Although Transcranial Magnetic Stimulation is safe with mild side effects, its efficacy declines with depth. It is commonly used in treating depression and anxiety, as well as in cognitive neuroscience research, often employing a protocol of high-frequency Transcranial Magnetic Stimulation (≥5 Hertz) for 20 minutes on the lower limb region of the bilateral cerebrum at 90% of the motor threshold.

selected physical therapy program

Other

The program provides a set of exercises focused on improving ankle and knee movements, building muscle strength, and increasing the range of motion. It details eight activities: Ankle Movements for controlling foot actions; Active Knee Extension to strengthen the quadriceps; Gluteus maximus Squeezes for gluteal muscle enhancement; Inner Range Quadriceps involving a towel for knee support; Bridging to elevate the pelvis; a Passive Stretching Program for gentle knee stretches; Trunk Rotation to improve mobility; and Ankle Flexion to bend the ankle without foot rotation. The exercises are designed for gradual progression based on patient tolerance.

Proprioceptive training

Other

The program outlines techniques for enhancing patient mobility and balance through various exercises. In modified plantigrade, patients practice stepping forward and backward while weight shifting, facilitated by a therapist's manual contact on the pelvis. Activities with footprint markers encourage active stepping, while resisted stepping involves pushing against elastic resistance. Utilizing a wobble board helps patients maintain balance and perform self-initiated tilts to improve stability. Prerequisite exercises for stair climbing, such as bridging and sit-to-stand transfers, include verbal cues to guide weight shifts and step placements, progressing from low to standard steps with therapist assistance as necessary.

Primary outcomes

  1. Assessment of gait function using Dynamic Gait Index:

    Time frame: At baseline and after 6 weeks

    For two groups a. Assessment of gait function using Dynamic Gait Index:

    Each item is scored on a 4-level ordinal scale.

    • Grade 3 = normal performance
    • Grade 2 = minimal impairment,
    • Grade 1 = moderate impairment,
    • Grade 0 = severe impairment. The maximum possible score is 24 points.

    The Dynamic gait index can be administered in 10 minutes and requires a box, 2 cones, stairs and twenty-foot walkway.

Secondary outcomes

  1. Assessment of ankle range of motion

    Time frame: At baseline and after 6 weeks

    To measure ankle angle during walking, a digital camera is set 1.5 m away from the subject at shoulder height. The testing involves having subjects maintain a standardized posture while moving naturally between two points, fifteen yards apart. Images and videos captured during this process are analyzed using Kinovea software for angle measurement.

  2. Assessment of step length

    Time frame: At baseline and after 6 weeks

    To measure step length during walking, a digital camera is set 1.5 m away from the subject at shoulder height. The testing involves having subjects maintain a standardized posture while moving naturally between two points, fifteen yards apart. Images and videos captured during this process are analyzed using Kinovea software for angle measurement.

  3. Assessment of step duration

    Time frame: At baseline and after 6 weeks

    To measure step duration during walking, a digital camera is set 1.5 m away from the subject at shoulder height. The testing involves having subjects maintain a standardized posture while moving naturally between two points, fifteen yards apart. Images and videos captured during this process are analyzed using Kinovea software for angle measurement.

  4. Assessment of cadence

    Time frame: At baseline and after 6 weeks

    To measure cadence during walking, a digital camera is set 1.5 m away from the subject at shoulder height. The testing involves having subjects maintain a standardized posture while moving naturally between two points, fifteen yards apart. Images and videos captured during this process are analyzed using Kinovea software for angle measurement.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 6, 2026
Registry last updated
Apr 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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