Virtual rehabilitation in patients with Parkinson's disease

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: H02.010.625 The randomization sequence will be generated by computer, through the randomization.com randomization program, considering two groups and 2 randomized blocks of 4 participants each, by an external researcher not involved in the study. This researcher will keep the randomization list confidential until the end of the study and organize in opaque and sequentially numbered envelopes, later sealed, the randomization sequence according to the coding of the order of admission in each group. Researcher 1 (P1) will be responsible for randomization, in order to maintain the confidentiality of the allocation. Researchers 2 and 3 (P2 and P3) will be responsible for performing the evaluation regarding the characterization measures and outcome measures of the sample, being blind in relation to the allocation in the study groups. The other researchers (students of undergraduate physiotherapy with supervision of preceptor students of the graduate program in Physiotherapy) will be the therapists of the study, who will be involved in the interventions, remotely for the participants of the Experimental Group, and face‐to‐face for the participants of the Control Group. Such researchers will open the envelopes, individually and sequentially, at the beginning of the intervention for each participant. The statistical analysis will be performed by an external researcher, who will be blind ed up regarding the allocation of patients in the groups, since the tabulation of the data will be performed by P1, which will tabulate the data whose groups will be identified with the name of two colors – red and yellow. Due to the nature of the intervention, neither therapists nor participants may be blinded. This is a randomized controlled two‐arm, uni‐blind clinical trial. Experimental group: 11 individ CONDITION: C10.228.140.079.862.500 Gait; Postural Balance; Ataxia; Motor Skills; Qualitu of Life; Cognition PRIMARY OUTCOME: The primary outcome of the present study will be motor function, measured from the Movement Disorders Society‐Unified Parkinson's Disease Rating Scale (MDS‐UPDRS) (GOETZ et. al, 2016), in part III. Part III of the scale has 18 items, and refers to a thorough motor evaluation with specific aspects, among them: stiffness, bradykinesia, tremor at rest, kinetic tremor and postural balance. INCLUSION CRITERIA: Individuals participating in a university extension project (AGruPar ‐ Group therapy assistance for individuals with Parkinson's disease) will be recruited for the study, considering as eligibility criteria: Having clinical diagnosis of Parkinson's disease; Be between 20 and 70 years old; Being on regular drug treatment for PD; Being in the Parkinson's disease stage classified from 1 to 3 on the Modified Hoehn and Yahr Scale (HOEHN, YAHR, 1967), considered with mild to moderate disability (SHENKMAN et. al, 2001); Manage to walk for at least 10 meters without personal assistance SECONDARY OUTCOME: Gait will be evaluated by the Functional Gait Assessment (FGA) instrument, which has shown valid and reliable in the evaluation of this outcome in PD. Gait will be evaluated by the Functional Gait Assessment (FGA) instrument, which has shown valid and reliable in the evaluation of this outcome in PD. The criteria for quality of life will be evaluated from the Parkinson Disease Questionnaire‐39 (PDQ‐39). This instrument is specific to measure the perception of quality of life in individuals with PD, containing 39 questions that are divided into eight domains: mobility, activities of daily living, emotional well‐being, stigma, social support, cognition, communication and body discomfort. The Timed Up and Go test (TUG), is simple and reliable, being one of the most used instruments for assessing mobility and balance in the national and international spheres. Independent adults without balance changes perform the test within 10 seconds; in individuals who are more dependent on basic transfers, the test is performed within 20 seconds, and for those individuals who are more dependent, it takes more than 20 seconds to complete the test. To perform cognitive assessment, the Montreal Cognitive Assessment (MoCA) scale, validated and adapted for the Brazilian population, with good psychometric properties, will be considered an important instrument for early detection of cognitive decline.
Epistemonikos ID: 9b948c86ee95d1e527be2afdbc9c0478abf69d2f
First added on: Feb 20, 2024