A Head-to-head Study Comparing the Functional Value of Two Models of Robotically Assisted Rehabilitation in SMA (Spinal Muscular Atrophy) Patients
NCT ID: NCT06322654
Last Updated: 2024-03-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2023-12-21
2027-07-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
1. Experimental: Robotically Assisted Locomotion
2. Comparison: Robotically Assisted Verticalization
SUPPORTIVE_CARE
SINGLE
Study Groups
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Robotically Assisted Locomotion
Robotically Assisted Locomotion
* Motor control training
* Locomotion and motor control training with elements of balance and coordination
* Verticalization training: standing frame device and vibration platform
* Cognitive therapy
Robotically Assisted Verticalization
Robotically Assisted Verticalization
* Motor control training
* Verticalization training with Standard Frame Devices
* Locomotion and motor control training with elements of balance and coordination
* Cognitive therapy
Interventions
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Robotically Assisted Locomotion
* Motor control training
* Locomotion and motor control training with elements of balance and coordination
* Verticalization training: standing frame device and vibration platform
* Cognitive therapy
Robotically Assisted Verticalization
* Motor control training
* Verticalization training with Standard Frame Devices
* Locomotion and motor control training with elements of balance and coordination
* Cognitive therapy
Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
21 Years
ALL
No
Sponsors
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Wiktor Dega University Orthopedic and Rehabilitation Hospital
OTHER
Responsible Party
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Principal Investigators
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Marek Jóźwiak
Role: PRINCIPAL_INVESTIGATOR
Wiktor Dega University Orthopedic and Rehabilitation Hospital
Locations
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Wiktor Dega University Orthopedic and Rehabilitation Hospital
Poznan, , Poland
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2023/ABM/01/00004/P/02
Identifier Type: -
Identifier Source: org_study_id
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