RTsMS and Body Weight-support Treadmill Training After Incomplete Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injuries (SCI)

• Registration Number: NCT06886308
• Lead Sponsor: Universidade Federal de Pernambuco

Brief Summary

The aim of this study is to assess the feasibility of combining rTsMS with BWSTT for gait and sensorimotor recovery in individuals with incomplete spinal cord injury.

Detailed Description

A randomized, sham-controlled, triple-blinded and parallel group trial (10 therapeutic sessions). Active or sham rTsMS will be combined with body weight-support treadmill training to verify the improvement of gait and sensory-motor function in patients with incomplete spinal cord injury. Assessments will be performed before, after 5 and 10 therapeutic sessions, though: (i) the WISCI-II Index; (ii) ASIA Impairment Scale (AIS), (iii) ASIA Lower Extremities Motor Scale (LEMS), (iv) Ashworth Modified Scale; (v) the Functional Independence Measure (SCIM-III), (vi) the Short Form Health Survey 36 (SF-36) and (vii) the Patient Global Impression of Change Scale - (PGICS).

Study Timeline

• Study Start: 2022-09-01
• Primary Completion: 2023-05-20
• Study Completion: 2023-08-31
• Status Verified: 2025-03
• Study First Submitted: 2025-03-10
• Study First Submitted QC: 2025-03-14
• Last Update Submitted: 2025-03-14
• Study First Posted: 2025-03-20
• Last Update Posted: 2025-03-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

• Diagnosed incomplete spinal cord injury established by a neurologist
• Chronic phase (>1 year)
• 18 and 60 years old, regardless of sex

Exclusion Criteria

• Community ambulators
• Could not maintain an orthostatic position for 30 seconds without assistance
• Associated neurological and/or orthopedic conditions
• Contraindications for rTsMS
• Diagnosis of cardiac dysfunction, angina, or hemodynamic disorders

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Changes on Walking Index for Spinal Cord Injury II (WISCI-II)	Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).	this is international scale, designed to identify an improvement in the ability to perform gait with spinal cord injury under environmental conditions. The WISCI-II is considered standard for gait evaluation of patients with spinal cord injury inserted in clinical trials. The WISCI-II categorizes patients' ability to perform a gait on 20 different levels by considering the following: distance traveled, need for assistance, assistance from others people, and gait devices. The higher the score, the greater the independence in gait.

Secondary Outcome Measures

Name	Time	Method
Changes on ASIA Impairment Scale (AIS)	Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).	Sensory-motor function was assessed using the AIS. This assessment measure is part of the guidelines provided by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI), created by the American Spinal Injury Association. Using the AIS, motor function was measured by the total score of the Upper Extremities Motor Scale (UEMS) and Lower Extremities Motor Scale (LEMS). The UEMS and LEMS are made up of the sum of the strength levels of ten main muscles. Each muscle was given a score ranging from '0' to '5', according to the manual muscle strength assessment scale. Sensory function was measured by the total score of two sensory components assessed in the AIS: 'light touch (LT)' and 'pinprick (PP)'. To assess sensory function, stimuli were applied to the dermatomes as described in the ASIA standardised manuals. The score for each component of the dermatome varies from '0 to 2': 0 = no sensation, 1 = altered sensation and 2 = preserved sensation.
Changes on Spinal cord independence measure (Self-Reported) III - (SCIM-III)	Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).	The scale evaluates a patient's ability to perform tasks related to spinal cord injury and tracks improvements in their functional capacity. The SCIM-III scale ranges from 0 to 100 points and is divided into three primary domains: self-care (feeding, bathing, dressing, and hygiene), breathing, sphincter control, and mobility (both indoor and outdoor activities, including transfers). The higher the score on the scale, the greater the functional independence.
Change from Modified Ashworth scale (MAS)	Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).	The Modified Ashworth Scale employs a 6-point system to measure the average resistance to passive movement at each joint. In this study, it will assess the following muscle groups: hip flexors and extensors, knee flexors and extensors, and ankle dorsiflexors and plantar flexors. The higher the score on the scale, the greater the degree of spasticity.
Changes on Short-Form Health Survey (SF-36)	Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).	The SF-36 is a multidimensional questionnaire consisting of 36 items, encompassed in eight scales or components: i. Functional capacity - 10 items, ii. Limitation by physical resources - 4 items, iii. Pain - 2 items, iv. General health status - 5 items, v. Vitality - 4 items, vi. Social Aspects - 2 items, vii. Limitation by emotional aspects - 3 items, viii. Mental Health - 5 items and one comparative question more for assessment between how current health conditions and a year ago.
Changes on Patient Global Impression of Change Scale - (PGICS)	After 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).	The PGICS is a one-dimensional measure in which individuals rate their improvement associated with intervention on a scale of 7 items ranging from "1 = no change" to "7 = Much better". This scale has already been validated in Brazil and has been used in clinical practice assays with spinal cord injury.

Trial Locations

Locations (1)

Applied Neuroscience Laboratory; 🇧🇷 Recife, Pernambuco, Brazil