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NCT Number: NCT06322654

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 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

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Key information

Conditions

SMA

Age range

Up to 21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Robotically Assisted Locomotion

Procedure
  • 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

Procedure
  • Motor control training
  • Verticalization training with Standard Frame Devices
  • Locomotion and motor control training with elements of balance and coordination
  • Cognitive therapy

Primary outcomes

  1. 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

  2. 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

  3. Functional assessment of patients using GMFM (Gross Motor Function Measure) scale

    Time frame: Through study completion, max. for 2.5 year every 6 months

  4. X-ray or ultrasound scan imaging assessment of the spine, hip joints and bone mineral density

    Time frame: Once per 1 year

  5. 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 outcomes

  1. Hospitalization during or between rehabilitations that take place each 6 months

    Time frame: Through study completion, max. for 2.5 year

  2. Occurence of discomfort during therapy requiring abrupt interruption or significant modification

    Time frame: Through study completion, max. for 2.5 year every 6 months

  3. Number of fractures

    Time frame: Through study completion, max. for 2.5 year

Study contacts

Contact information is provided by the study sponsor or research team.

Marek Jóźwiak

CONTACT

[email protected]

696052475 ext. +48

Radosław Rutkowski

CONTACT

[email protected]

696052475

Sponsors and collaborators

Lead sponsor

Wiktor Dega University Orthopedic and Rehabilitation Hospital

Other

Registry information

Official study 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

Acronym: SMArt

Important dates

Study start
2023
Primary completion
2027
Study completion
2027
First posted
Mar 21, 2024
Registry last updated
Mar 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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