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

Pomeranian Medical University Szczecin

Status: Terminated

Conditions: Multiple Sclerosis

Treatments: Behavioral: Reh1,Reh2

Study type: Interventional

Funder types: Other

Identifiers

NCT03693118

PomeranianMU2018

Details and patient eligibility

About

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.

Enrollment: 86 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: Single Blind

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86 participants in 2 patient groups

Grup1, Grup2

Experimental group

Treatment:

Behavioral: Reh1,Reh2

Grup1,Grup2

Experimental group

Treatment:

Behavioral: Reh1,Reh2