Effectiveness of Powerball System in People With Multiple Sclerosis (EMPOW)

Universidad Rey Juan Carlos

Status: Completed

Conditions: Multiple Sclerosis; Neurologic Disorder

Treatments: Other: Conventional treatment; Device: NDS-Powerball®,

Study type: Interventional

Funder types: Other

Identifiers

NCT05895734

EM_POWERBALL23

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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25 participants in 2 patient groups

Powerball

Experimental group

Description:

Rehabilitation using the Powerball system

Treatment:

Device: NDS-Powerball®,

Conventional treatment

Active Comparator group

Description:

Rehabilitation by conventional treatment

Treatment:

Other: Conventional treatment