Robot-assisted Arm Training in Multiple Sclerosis (RAMSES)
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|ClinicalTrials.gov Identifier: NCT03561155|
Recruitment Status : Completed
First Posted : June 19, 2018
Last Update Posted : June 19, 2018
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis Rehabilitation||Device: Robot assisted treatment (Amadeo®) Other: Conventional treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Effects of High-intensity Robot-assisted Training in Hand Function Recovery and ADL Independence in Individuals With Multiple Sclerosis: a Randomized Controlled Single-blinded Trial|
|Actual Study Start Date :||November 2014|
|Actual Primary Completion Date :||September 1, 2017|
|Actual Study Completion Date :||May 1, 2018|
Experimental: Robot assisted treatment
The experimental group (EG) will undergo a robot-assisted arm training using Amadeo® (Tyromotion-Austria).
Device: Robot assisted treatment (Amadeo®)
The protocol will consist of exercises as follows:
passive modality , passive/plus modality , assisted therapy and Balloon.
Other Name: Robot assisted treatment
Active Comparator: Conventional treatment
The conventional group (CG) will undergo robot unassisted treatment (Conventional treatment).
Other: Conventional treatment
The protocol will consist of exercises as follow:
upper limb mobilization, facilitation of movements and active tasks. The exercises will be focused on improving muscle strength, finger extension and flexion and motor control
- Action Research Arm test [ Time Frame: Up to 6 weeks ]Assesses upper limb functioning using observational methods
- Fugl-Meyer Assessment Motor Scale - Arm Section [ Time Frame: Up to 6 weeks ]Evaluates and measures recovery in post-stroke hemiplegic patients
- Motor Activity Log [ Time Frame: Up to 6 weeks ]Semi-structured interview to assess arm function.
- Tremor Severity Scale [ Time Frame: Up to 6 weeks ]A clinical rating scale which measured the severity of tremor
- Nine Hole Peg Test [ Time Frame: Up to 6 weeks ]Measures finger dexterity
- Motricity Index [ Time Frame: Up to 6 weeks ]Measures of strength in upper limb
- Amadeo® hand muscle strength (Newton) [ Time Frame: Up to 6 weeks ]Measures of muscle strenght using the robotic device
- Visual anolgue Scale for tiredness and fatigue [ Time Frame: Up to 6 weeks ]Measures of tirediness and fatigue on a 10-point likert scale
- Multiple Sclerosis Quality of Life-54 [ Time Frame: Up to 6 weeks ]Measures of a multidimensional health-related quality of life measure that combines both generic and MS-specific items into a single instrument.
- Assessment of Life Habits [ Time Frame: Up to 6 weeks ]Assesses participants on 77 life habits from daily activities to social participation across 12 domains.
- UL electromyographic analysis of muscle activation [ Time Frame: Up to 6 weeks ]Instrumental assessment of muscle activity during a reaching task
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03561155
|Verona, Italy, 37134|
|Principal Investigator:||Nicola Smania, Professor||Universita di Verona|