NCT06322654Recruiting
A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients
A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA Patients: Single-center, Randomized, Single-blinded, Comparative Study of a Robotically Active Verticalization Model Versus Robotically Assisted Locomotion Model
Source: ClinicalTrials.gov · Last updated 21 Mar 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 26 Jan 2024
- Start date
- Dec 2023
- Primary completion date
- Mar 2027
- Lead sponsor
- Wiktor Dega University Orthopedic and Rehabilitation Hospital
- Diseases
- Spinal muscular atrophy
- NCT number
- NCT06322654
What you commit to
- Study type: Interventional
- Planned participants: 200
- From Dec 2023 to the primary completion date, Mar 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Advanced osteoporosis with multiple fractures prior to treatment
Other illness
- Cardio-respiratory disorders requiring invasive ventilation
Other
- Functional deterioration during the rehabilitation process in the range of scales appropriately selected for the SMA type: Prechtl, HINE, CHOP-INTEND, HFMS, RULM
- Lack of cooperation with the therapist
- Other functional indications preventing exercise
Who the study is looking for
- Signing of informed consent to participate in the experiment by the participant or the participant's parent/legal guardian
- Diagnosis of SMA (spinal muscular atrophy 1-4) confirmed by genetic testing, symptomatic or pre-symptomatic
- Age between 0 and 21 years of age (will be determined on the day of starting participation in the project based on the date of birth)
- Treatment under a drug program for spinal muscular atrophy, provided that the patient has a diagnosis of spinal muscular atrophy at the date of eligibility.
Age in the registry: - to 21 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Wiktor Dega University Orthopedic and Rehabilitation Hospital Coordinator of this site? Confirm its status | Poznan | Poland | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.