Actively Recruiting

Phase Not Applicable
Age: 0 - 21Years
All Genders
NCT06322654

A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients

Led by Wiktor Dega University Orthopedic and Rehabilitation Hospital · Updated on 2024-03-21

200

Participants Needed

1

Research Sites

184 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

A head-to-head study comparing the functional value of two models of robotically assisted rehabilitation in patients with SMA. A single-center, randomized, single-blinded, comparative study of Robotically Assisted Verticalization versus Robotically Assisted Locomotion. The objective of research: The main goal of the project is to determine the optimal robotically assisted rehabilitation model for people with SMA depending on age and baseline functional status. The study consists of a head-to-head comparison of two rehabilitation models. 1. Research period: 4 years 2. Patients age: 0-21 y.o. 3. Group size: 200 patients (100 patients in each group) 4. Assignment of patients to study groups in a randomised manner

CONDITIONS

Official Title

A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients

Who Can Participate

Age: 0 - 21Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Signed informed consent by participant or legal guardian
  • Confirmed diagnosis of spinal muscular atrophy (types 1-4) by genetic testing, symptomatic or pre-symptomatic
  • Age between 0 and 21 years at study start
  • Currently receiving drug treatment for spinal muscular atrophy at eligibility
Not Eligible

You will not qualify if you...

  • Cardio-respiratory disorders needing invasive ventilation
  • Advanced osteoporosis with multiple fractures before treatment
  • Functional decline during rehabilitation as measured by SMA-specific scales
  • Lack of cooperation with therapist
  • Other functional issues preventing exercise

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 1 location

1

Wiktor Dega University Orthopedic and Rehabilitation Hospital

Poznan, Poland, 61-545

Actively Recruiting

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Research Team

M

Marek Jóźwiak

CONTACT

R

Radosław Rutkowski

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

SINGLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

2

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