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TerminatedNCT03693118Updated Oct 2, 2018

Influence of Cognitive Function Software Therapy on the Improvement of Manual Skills in Multiple Sclerosis Patients

An interventional study of Reh1,Reh2 in Multiple Sclerosis, sponsored by Pomeranian Medical University Szczecin. Terminated at 1 site in Poland. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2018-10-02.

Sponsored by Pomeranian Medical University Szczecin · Not applicable, Interventional, and Treatment

Why this study was terminated
the study was completed

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Jan 2018, registered Sep 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
86
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study summary

Multiple Sclerosis (MS) is a chronic demyelinating disease of the central nervous system leading to the impairment of motor, visual and cognitive functions. A standardized rehabilitation of cognitive functions can be provided by a systematized treatment program devised to improve neurological patients' quality of life. The degree of difficulty of the computerized tasks was adapted to a patient's predispositions and modified once a desirable improvement in the practiced skill has reached.

The aim of the study was to assess the influence of cognitive therapy by means of the cognitive software on manual dexterity in patients with multiple sclerosis. We also attempted to establish whether factors like age, sex and Expanded Disability Status Scale (EDSS) scores contribute to the outcomes of that therapy. All patients enrolled will have a documented history of MS disease prior to study enrollment. The EDSS scores varied between 1.5-4 (mean score 2.1). The Nine Hole Peg Test (NHPT), administered to all of the patients, was used to evaluate the subjects' manual dexterity. Having been administered the NHPT test the initial 86-patient group was reduced to a cohort of 40 subjects qualified for the study, who were subsequently randomly divided into two groups - the study and the control - each consisting of 20 subjects. Three times a week the study group received the upper limb treatment by means of the cognitive function platform. They were expected to achieve 96 levels of visuo-motor coordination in 3 months or the treatment was to be terminated. After completing each task the patient would move on to a higher level of difficulty. Failure meant having to redo that particular task. One training session lasted 20 min., after which the patient could take a break.

Having completed the training each patient was administered the NHPT test again in view of assessing the efficiency of their upper limb. Due to progressive deterioration of health and other factors only 10 patients managed to complete the training.

02

Conditions studied

  • Multiple Sclerosis

Keywords

  • manual therapy; multiple sclerosis; rehabilitation; motor cortex; neuroplasticity
03

In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's enrollment of 86 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Pomeranian Medical University Szczecin is the lead sponsor of 68 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion criteria:

MS clinically diagnosed based on McDonald's criteria of 2011 The EDSS between 1.5-4; relapsing-remitting form MS;

exclusio criteria Mental disorders, alcoholism, severe vision disorders including diplopia coinciding upper limb therapy

-

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Factorial assignment
Masking
Single (Participant)
Enrollment
86 participants (actual)

Study arms

  • Experimental
    Grup1, Grup2

    Behavioral: Reh1,Reh2

  • Experimental
    Grup1,Grup2

    Behavioral: Reh1,Reh2

Interventions

  • BehavioralReh1,Reh2

    The initial group comprised 86 subjects including. The Nine Hole Peg Test (NHPT), administered to all of the patients, was used to evaluate the subjects' manual dexterity. The standardized scale enabled obtaining scores of high validity (right: r= 0.984, left: r = 0.993). Having been administered the NHPT test the initial 86-patient group was reduced to a cohort of 40 subjects qualified for the study, who were subsequently randomly divided into two groups - the study and the control - each consisting of 20 subjects. Three times a week the study group received the upper limb treatment by means of the cognitive function platform. They were expected to achieve 96 levels of visuo-motor coordination in 3 months or the treatment was to be terminated. Prior to the first session of the treatment the patients were provided with all relevant instructions and information about the test displayed on the monitor. They could also choose which hand they would start with.

06

What researchers measure

Primary outcomes

  1. Hand therapy using cognitive functions in patients with MS

    Three times a week the study group received the upper limb treatment by means of the cognitive function platform. They were expected to achieve 96 levels of visuo-motor coordination in 3 months or the treatment was to be terminated. After completing each task the patient would move on to a higher level of difficulty. Failure meant having to redo that particular task. One training session lasted 20 min., after which the patient could take a break.

    Time frame: 3 months

07

Study locations

1 site
  • Departmen of Neurology
    Szczecin, Unii Lubelskiej 71-228, Poland
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03693118
Lead sponsor
Pomeranian Medical University Szczecin
Responsible party
Pawlukowska Wioletta (Study Director: Przemysław Nowacki MD, PhD, Pomeranian Medical University Szczecin) — Principal investigator
First posted
Oct 2, 2018
Start date
Jan 13, 2018
Primary completion
Apr 20, 2018
Completion
May 30, 2018
Last update
Oct 2, 2018

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

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