Effectiveness of Powerball System in People With Multiple Sclerosis

NCT ID: NCT05895734

Last Updated: 2023-07-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-10

Study Completion Date

2023-07-10

Brief Summary

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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.

Detailed Description

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Conditions

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Neurologic Disorder Multiple Sclerosis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Powerball

Rehabilitation using the Powerball system

Group Type EXPERIMENTAL

NDS-Powerball®,

Intervention Type DEVICE

Rehabilitation using the Powerball system

Conventional treatment

Rehabilitation by conventional treatment

Group Type ACTIVE_COMPARATOR

Conventional treatment

Intervention Type OTHER

Rehabilitation by conventional treatment

Interventions

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NDS-Powerball®,

Rehabilitation using the Powerball system

Intervention Type DEVICE

Conventional treatment

Rehabilitation by conventional treatment

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Universidad Rey Juan Carlos

OTHER

Sponsor Role lead

Responsible Party

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Josue Fernandez Carnero

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Universidad Rey Juan Carlos

Alcorcón, Madrid, Spain

Site Status

Countries

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Spain

Other Identifiers

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EM_POWERBALL23

Identifier Type: -

Identifier Source: org_study_id

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