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.

Study Overview

• Status: Completed
• Conditions: Stroke; Transcranial Magnetic Stimulation; Gait Disorders, Neurologic; Proprioceptive Training
• Intervention / Treatment: Device: Transcranial Magnetic Stimulation; Other: selected physical therapy program; Other: proprioceptive training

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • the Qasr El Eyni Hospitals and Private clinics.

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

Thirty patients with stroke from both sexes.

2) Age will range from 50 to 60 years old.

3) Duration of stroke ≥ 6 months.

4) Spasticity of the lower limb ranges from 1+ to 2 according to modified ashworth scale

5) The patients able to walk with or without assistive device.

6) Body mass index is less than 30 kg/m2.

7) Patients with sufficient cognitive abilities that enables them to understand and follow instructions (Mini-Mental State Examination scale >24).

Exclusion Criteria:

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

5- Cardiac pacemaker

6- Metallic Implants.

7- Aphasia, deafness or blindness

7. Deformities or contractures of the lower limbs

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: Transcranial Magnetic Stimulation and proprioceptive training; this group received a transcranial magnetic stimulation session for 20 min ,15 min of strengthening of lower limb and bridging exercises, and passive stretching for lower limb, and adding five exercises of proprioceptive training post Transcranial Magnetic Stimulation session for 15 min.	Device: Transcranial Magnetic Stimulation; 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.; Other: selected physical therapy program; 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.; Other: proprioceptive training; 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.
Active Comparator: Transcranial Magnetic Stimulation only; this group received only Rtms session for 20 min and 30 min of strengthening of lower limb and bridging exercises and passive stretching for lower limb	Device: Transcranial Magnetic Stimulation; 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.; Other: selected physical therapy program; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of gait function using Dynamic Gait Index:	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.	At baseline and after 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assessment of ankle range of motion	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.	At baseline and after 6 weeks
Assessment of step length	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.	At baseline and after 6 weeks
Assessment of step duration	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.	At baseline and after 6 weeks
Assessment of cadence	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.	At baseline and after 6 weeks

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Actual): August 1, 2025
• Study Completion (Actual): October 1, 2025

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: April 1, 2026
• First Posted (Actual): April 6, 2026

Study Record Updates

• Last Update Posted (Actual): April 6, 2026
• Last Update Submitted That Met QC Criteria: April 1, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Stroke; Gait Disorders, Neurologic; Therapeutics; Magnetic Field Therapy; Transcranial Magnetic Stimulation
• Other Study ID Numbers: Mahmoud PhD

Drug and device information, study documents

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