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

NCT06886308 | Completed DMC

• 1 other identifier: rTsMS_BWSTT_iSCI
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries (SCI)

Keywords

spinal cord injury; gait; body weight- support treadmill training; Repetitive Trans-spinal Magnetic Stimulation; Trans-spinal Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

• Changes on Walking Index for Spinal Cord Injury II (WISCI-II)

  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.

  Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).

Secondary Outcomes (5)

• Changes on ASIA Impairment Scale (AIS)

  Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).

• 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).

• Change from Modified Ashworth scale (MAS)

  Before the intervention (baseline), after 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).

• 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).

• Changes on Patient Global Impression of Change Scale - (PGICS)

  After 5 sessions (5 days of intervention) and 10 sessions (10 days of intervention).

Study Arms (2)

high-frequency rTsMS + BWSTT

EXPERIMENTAL

a randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between high-frequency rTsMS and body weight-support treadmill training in improving the gait and sensory-motor function of adult patients with chronic incomplete spinal cord injury.

Device: Repetitive trans-spinal magnetic stimulation

sham rTsMS + BWSTT

SHAM COMPARATOR

a randomized, sham-controlled, double-blinded and parallel group trial (10 therapeutic sessions) with the combination between sham rTsMS and body weight-support treadmill training in improving the gait and sensory-motor function of adult patients with chronic incomplete spinal cord injury.

Device: Repetitive trans-spinal magnetic stimulation

Interventions

Repetitive trans-spinal magnetic stimulation DEVICE

For repetitive trans-spinal magnetic stimulation - rTsMS (high-frequency or sham), volunteers will be positioned comfortably in a lateral decubitus position. High-frequency rTsMS will be applied with an eight-shaped coil over the tenth thoracic vertebra (10 Hz; 100 pulses per train, 20-second interval between trains; 100% resting motor threshold). For sham rTsMS, two coils will be used: (i) a coil connected to the stimulator will be placed behind the patient (away from the spine) to generate the characteristic sound, and (ii) another coil, disconnected from the stimulator, will be placed on the tenth thoracic vertebra. Both real and sham stimulation will last 20 minutes. Gait training with body weight support will be performed on a Biodex Rehabilitation treadmill for 20 minutes. Researchers will assist the patient in foot placement, knee extension, and pelvis/trunk alignment. Body weight support and treadmill speed will be adjusted based on the patient's performance.

Also known as: Body Weight-support Treadmill Training

high-frequency rTsMS + BWSTT; sham rTsMS + BWSTT

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universidade Federal de Pernambuco: lead

Study Sites (1)

Applied Neuroscience Laboratory

Recife, Pernambuco, 50670-900, Brazil

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Officials

• Vinicius Cipriano, Student of Physical Therapy

  Applied Neuroscience Laboratory

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master in Physical Therapy

Study Record Dates

• First Submitted: March 10, 2025
• First Posted: March 20, 2025
• Study Start: September 1, 2022
• Primary Completion: May 20, 2023
• Study Completion: August 31, 2023
• Last Updated: March 20, 2025

Record last verified: 2025-03

Locations

BR (1)