Effectiveness of Powerball System in People With Multiple Sclerosis

NCT05895734 | Completed DMC

• 1 other identifier: EM_POWERBALL23
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Neurologic Disorder; Multiple Sclerosis

Outcome Measures

Primary Outcomes (2)

• Isometric hand strength:

  Measured through the JAMAR® fist dynamometer, which is a sealed hydraulic system with an adjustable space to adapt to the handgrip of each patient. The JAMAR® dynamometer has been widely cited and is considered the gold standard for the assessment of handgrip strength. In turn, its test-retest and inter-rater reliability is excellent in different populations. The patient held the tool with the upper limb at 0º of abduction and rotation; elbow flexed at 90º and the forearm in neutral position; wrist between 0 and 15º of radial deviation; and performed a maximum grip for 3 seconds with his 5 fingers, quantifying the force exerted in kilograms. Three measurements were taken with each hand, always starting with the dominant hand; once the three measurements were taken, the mean of these was used.

  1 minute

• Isometric pincer force

  A Baseline Pinch Gauge® was used to assess pinch force. Three presses were performed with the maximum possible force for 3 seconds, alternating between the dominant and non-dominant hand; the force obtained is marked in kilograms by the dynamometer. Once the 3 results were obtained, the average of these was obtained.

  3 minutes

Secondary Outcomes (7)

• Box and Block Test (BBT)

  3 minutes

• Nine Hole Peg Test (NHPT)

  2 minutes

• Abilhand test

  3 minutes

• Fatigue Severity Scale (FSS)

  2 minutes

• Multiple Sclerosis Impact Scale (MSIS-29)

  3 minutes

Study Arms (2)

Powerball

EXPERIMENTAL

Rehabilitation using the Powerball system

Device: NDS-Powerball®,

Conventional treatment

ACTIVE COMPARATOR

Rehabilitation by conventional treatment

Other: Conventional treatment

Interventions

NDS-Powerball®, DEVICE

Rehabilitation using the Powerball system

Powerball

Conventional treatment OTHER

Rehabilitation by conventional treatment

Conventional treatment

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

Location

MeSH Terms

Conditions

Nervous System Diseases; Multiple Sclerosis

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 25, 2023
• First Posted: June 9, 2023
• Study Start: January 10, 2023
• Primary Completion: July 10, 2023
• Study Completion: July 10, 2023
• Last Updated: July 14, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)