A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients
- Conditions
- SMA
- Interventions
- Procedure: Robotically Assisted VerticalizationProcedure: Robotically Assisted Locomotion
- Registration Number
- NCT06322654
- Lead Sponsor
- Wiktor Dega University Orthopedic and Rehabilitation Hospital
- Brief Summary
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
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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.
- Cardio-respiratory disorders requiring invasive ventilation
- Advanced osteoporosis with multiple fractures prior to treatment
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Robotically Assisted Verticalization Robotically Assisted Verticalization - Robotically Assisted Locomotion Robotically Assisted Locomotion -
- Primary Outcome Measures
Name Time Method X-ray or ultrasound scan imaging assessment of the spine, hip joints and bone mineral density Once per 1 year Assessment of the quality of life of patients and their caregivers using Pediatric Quality of Life Inventory ver. 4.0 Through study completion, max. for 2.5 year every 6 months Clinical assessment of patients using Children's Hospital Of Philadelphia Infant Test Of Neuromuscular Disorders, Revised Upper Limb Module, Hammersmith Functional Motor Scale Through study completion, max. for 2.5 year every 6 months Clinical assessment of patients using Balance test minimum 1 min., Self-walk test of at least 2 meters, 6-minute gait test, Up&Go test, 10 meters gait test, hip range of motion and muscle strength evaluation. Through study completion, max. for 2.5 year every 6 months Functional assessment of patients using GMFM (Gross Motor Function Measure) scale Through study completion, max. for 2.5 year every 6 months
- Secondary Outcome Measures
Name Time Method Occurence of discomfort during therapy requiring abrupt interruption or significant modification Through study completion, max. for 2.5 year every 6 months Hospitalization during or between rehabilitations that take place each 6 months Through study completion, max. for 2.5 year Number of fractures Through study completion, max. for 2.5 year
Trial Locations
- Locations (1)
Wiktor Dega University Orthopedic and Rehabilitation Hospital
🇵🇱Poznań, Poland