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Recruiting NCT06322654

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

No phase Interventional SMA

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Robotically Assisted Locomotion, Robotically Assisted Verticalization.
Who it may be relevant to
Registry conditions: SMA. Basic parameters: up to 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Poland
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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

Interventions

  • Procedure 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
  • Procedure 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

Primary outcome measures

  • Clinical assessment of patients using Children's Hospital Of Philadelphia Infant Test Of Neuromuscular Disorders, Revised Upper Limb Module, Hammersmith Functional Motor Scale [Time frame: 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. [Time frame: Through study completion, max. for 2.5 year every 6 months]
  • Functional assessment of patients using GMFM (Gross Motor Function Measure) scale [Time frame: Through study completion, max. for 2.5 year every 6 months]
  • X-ray or ultrasound scan imaging assessment of the spine, hip joints and bone mineral density [Time frame: Once per 1 year]
  • Assessment of the quality of life of patients and their caregivers using Pediatric Quality of Life Inventory ver. 4.0 [Time frame: Through study completion, max. for 2.5 year every 6 months]
Secondary outcome measures (3)
  • Hospitalization during or between rehabilitations that take place each 6 months [Time frame: Through study completion, max. for 2.5 year]
  • Occurence of discomfort during therapy requiring abrupt interruption or significant modification [Time frame: Through study completion, max. for 2.5 year every 6 months]
  • Number of fractures [Time frame: Through study completion, max. for 2.5 year]

Eligibility criteria

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Poland · 1 center
  • Wiktor Dega University Orthopedic and Rehabilitation Hospital — Poznan

Identifiers

NCT: NCT06322654 · 2023/ABM/01/00004/P/02

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗