NCT03693118

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

Terminated NA Last updated 2 October 2018

What this trial tests

NA trial testing Reh1,Reh2 in Multiple Sclerosis in 86 participants. Terminated before completion.

Timeline

13 January 2018

Primary endpoint
20 April 2018

30 May 2018

Quick facts

Lead sponsor	Pomeranian Medical University Szczecin
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	factorial
Masking	single
Primary purpose	treatment
Enrollment	86
Start date	13 January 2018
Primary completion	20 April 2018
Estimated completion	30 May 2018
Sites	1 location across Poland

Drugs / interventions tested

• Reh1,Reh2

Conditions studied

• Multiple Sclerosis — all drugs for Multiple Sclerosis →

Sponsor

Pomeranian Medical University Szczecin

Who can join

Adults 18 to 65, any sex, with Multiple Sclerosis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Influence of RehaCom Therapy on the Improvement of Manual Skills in Multiple Sclerosis Subjects.
   Pawlukowska W, Dobrowolska N, Szylinska A, Koziarska D, et al · · 2020 · cited 6× · PMID 32392653 · DOI 10.5535/arm.2020.44.2.142