Clinical trial NCT05895734: Effectiveness of Powerball System in People With Multiple Sclerosis
Official title: Effectiveness of Upper Limb Rehabilitation Using the Powerball System in People With Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neurologic Disorder
Multiple Sclerosis
Lead sponsor: Universidad Rey Juan Carlos
Sponsor class: OTHER
First posted: 2023-06-09
Enrollment: 25
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: There is a high percentage of impairment in the upper limbs (UL) in patients with multiple sclerosis (MS), being muscle strength and hand dexterity a determining factor for the preservation of functional activities, constituting the basis of independence and quality of life. The aim of this study is to determine the effects of a training protocol on UL muscle strength, through the NDS-Powerball® system, in combination with conventional physiotherapy, during 8 weeks in terms of muscle strength, coordination, fatigue, functionality and quality of life in people with MS.


Eligibility criteria: Inclusion Criteria:

* Age between 20 and 60 years
* Diagnosed with MS according to McDonald criteria with an evolution time of more than two years
* Evaluation in the Kurtzke Disability Status Scale in Multiple Sclerosis (EDSS) with a score between 3.5 and 6
* Score less than or equal to 4 on the "Pyramidal Function" section of the EDSS functional scale
* Stable medical treatment for at least six months prior to surgery
* Muscle tone in the upper extremities no greater than 2 points on the modified Ashworth scale.
* Muscle balance equal to or greater than 3 in the upper extremity
* Absence of cognitive impairment with ability to understand instructions and score equal to or greater than 4 on the Minimental Test.

Exclusion Criteria:

* Diagnosis of another neurological disease or musculoskeletal alteration other than MS
* Diagnosis of any cardiovascular, respiratory or metabolic disease or other conditions that may interfere with this study
* Having suffered an exacerbation or hospitalization in the last three months before starting the assessment protocol, or during the therapeutic intervention process.
* Having received treatment with botulinum toxin in the six months prior to the start of the study
* Presence of visual alterations not corrected by means of ocular devices.

Primary outcomes:
measure: Isometric hand strength:
timeFrame: 1 minute
measure: Isometric pincer force
timeFrame: 3 minutes
Secondary outcomes:
measure: Box and Block Test (BBT)
timeFrame: 3 minutes
measure: Nine Hole Peg Test (NHPT)
timeFrame: 2 minutes
measure: Abilhand test
timeFrame: 3 minutes
measure: Fatigue Severity Scale (FSS)
timeFrame: 2 minutes
measure: Multiple Sclerosis Impact Scale (MSIS-29)
timeFrame: 3 minutes
measure: Customer Satisfaction Questionnaire (CSQ8)
timeFrame: 2 minutes
measure: Likert satisfaction questionnaire for the experimental group
timeFrame: 1 minute
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Universidad Rey Juan Carlos
state: Madrid
Study officials:
References: