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Clinical Trials/NCT05895734
NCT05895734
Completed
Not Applicable

Effectiveness of Upper Limb Rehabilitation Using the Powerball System in People With Multiple Sclerosis

Universidad Rey Juan Carlos1 site in 1 country25 target enrollmentJanuary 10, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Neurologic Disorder
Sponsor
Universidad Rey Juan Carlos
Enrollment
25
Locations
1
Primary Endpoint
Isometric pincer force
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 10, 2023
End Date
July 10, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Josue Fernandez Carnero

Principal Investigator

Universidad Rey Juan Carlos

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.

Outcomes

Primary Outcomes

Isometric pincer force

Time Frame: 3 minutes

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.

Isometric hand strength:

Time Frame: 1 minute

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.

Secondary Outcomes

  • Fatigue Severity Scale (FSS)(2 minutes)
  • Likert satisfaction questionnaire for the experimental group(1 minute)
  • Box and Block Test (BBT)(3 minutes)
  • Abilhand test(3 minutes)
  • Nine Hole Peg Test (NHPT)(2 minutes)
  • Multiple Sclerosis Impact Scale (MSIS-29)(3 minutes)
  • Customer Satisfaction Questionnaire (CSQ8)(2 minutes)

Study Sites (1)

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