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IRCT20191216045759N1 IRCT 2019-12-30 The University of Lahore Effect of kinesio taping in Parkinson's disease Effectiveness of kinesio taping in addition to routine physical therapy on balance, gait and quality of life in patients with Parkinson's disease 2019-03-10 anticipated 40 Complete https://irct.ir/trial/44281 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study was designed to be a parallel group randomized controlled trial. After baseline assessment, eligible patients were randomly assigned (in a 1:1 ratio) to either kinesio taping + routine physical therapy (kinesio taping intervention group) or routine physical therapy (control group). Computer generated randomization assignments were designed by an independent statistician and randomization was done by one of the research team member who was not involved in patient recruitment or assessment or data analysis. Randomization is without stratification, with the use of permuted-block randomization; the randomization assignments were kept in opaque, sealed envelopes and unsealed by a researcher after baseline testing.Outcome assessors were unaware of group assignment, Blinding description: After randomisation, study participants were only informed about the content of their allocated programme by their therapist, remaining unaware of the intervention in the other group. Patient brochure stated that the study purpose was to evaluate the effects of physical therapy interventions on Parkinson’s disease symptoms, without mentioning that one of the programmes was considered a control intervention. Information about the details of both programmes was not provided except for similarities across both groups (treadmill training, aerobic exercise three times per week). Both programmes were personalised to the patient’s abilities to ensure all eligible patients could complete the programme. Researchers who assessed outcomes or did data analyses were masked to group allocation. Patients were instructed not to talk about the content of their exercise programme during the post intervention visit and could contact their therapist in case of any problems during trial participation. Moreover, if two or more study participants were in the clinic/hospital at the same time, they were assigned to different treatment areas without any opportunity to observe each other or their treatment times were rearranged to prevent unintended crossover. During outcomes assessment patients were covered in such a way that kinesio tape could not be visible to assessor and it also did not impede patient’s abilities to perform activities. N/A Parkinson's disease. Intervention 1: Intervention group: Kinesio taping plus routine physical therapy. Intervention 2: Control group: Routine physical therapy. Yes - There is a plan to make this available What will be shared: IPD, study protocol, statistical analysis plan, informed consent form and clinical study report will be shared for primary and secondary outcome measure with interested research after considering the ethics and confidentiality. When: Data will be available after 6 months of publication for 3 consecutive years. To whom: Data will only be shared with individual researcher and academic researchers working in movement disorders. Data will not be shared for any commercial purposes/businesses for any reasons. Conditions: Data can be used under confidentiality and ethics. Where to obtain: Data can be obtained by emailing at haiderullah@live.com. Mobile number 0092 331 4127210 How to obtain: Simple email can do this. But this can take up to 4 weeks depends on busy schedule of investigator. Comments:
public Muhammad Haider Ullah Khan
90-A, Civil Lines, Johar Road, Sheikhupura
Sheikhupura Pakistan 39350 +92 56 3785097 haiderullah@live.com The University of Lahore scientific Muhammad Haider Ullah Khan
90-A, Civil Lines, Johar Road, Sheikhupura
Sheikhupura Pakistan 39350 +92 56 3785097 haiderullah@live.com The University of Lahore Pakistan Idiopathic Parkinson’s disease clinically diagnosed by neurologist (according to the UK PDS Brain Bank criteria). Both males and females; 50 - 80 years of age. Modified Hoehn and Yahr stage 2.5 to 3 Movement Disorder Society-Unified Parkinson’s Disease Rating Scale III subscore ‘gait’ or ‘postural stability’ ≥ 1 Receive a stable dopaminergic medication dose (both levo-dopa and/or a dopamine agonist are allowed) for one month before the study 50 years 80 years Both A Mini Mental State Examination score < 24/30 Diagnosed with any other neurological disease other than PD Patient underwent surgery i.e. deep brain stimulation and lesioning surgery (thalamotomy, pallidotomy, subthalamotomy) Fixed vertebral deformities (ankylosing spondylitis, vertebral pathology such as fracture, spinal cord pathology such as syrinx, idiopathic or degenerative scoliosis). Have severe cardiovascular or pulmonary problems Have lower extremity disorders (e.g. deformities, fractures, rheumatologic disease and operations). Visual or acoustic limitations A major change in medicine existed during the training period Any skin or allergic reaction to kinesio tape Rehabilitation Rehabilitation Intervention group: Kinesio taping plus routine physical therapy Control group: Routine physical therapy Balance. Timepoint: Baseline assessment i.e. before intervention (t0), on the day of second session of treatment but before treatment of patient (t1), after end of treatment sessions (t2) and after 3 months of intervention (t3). Method of measurement: Berg balance scale (BBS) and Timed Up and Go Test (TUG). BBS is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4. 0 denotes inability to complete the item, and 4 the ability to accomplish the task independently (total score range, 0–56; higher = better performance). Scores of less than 45 out of 56 are accepted as indicative of balance disorders in the elderly, while scores of less than 43.5 out of 56 are accepted as indicative in Parkinson’s disease. The TUG test is aimed at assessing mobility, balance, walking ability, and fall risk in older adults. The patient is asked to get up from a standard chair, walk at a comfortable and safe speed to a line 3 m away, turn at the line and walk back to the chair to sit down. In patients with Parkinson’s disease, a score higher than 7.95 s may indicate a high risk of falling. Gait. Timepoint: Baseline assessment i.e. before intervention (t0), on the day of second session of treatment but before treatment of patient (t1), after end of treatment sessions (t2) and after 3 months of intervention (t3). Method of measurement: GAITRite Platinum and Functional gait assessment. Gait function was measured using GAITRite Platinum system (GaitRite, CIR system Inc., USA, 2008). As the subject walked along the walkway, the sensors captured each footfall as a function of time and transferred the gathered information to a personal computer for processing into footfall patterns. The parameters evaluated will be gait velocity, cadence, and step length, and the mean of three repetitions will be used. Functional Gait Assessment: The FGA is a 10-item gait test. Each item is scored on a 4-pointordinal scale with scores of 0, 1, 2, and 3. The maximum total score is 30; higher scores represent better balance and gait ability. Quality of Life. Timepoint: Baseline assessment i.e. before intervention (t0), after end of treatment sessions (t1) and after 3 months of intervention (t2). Method of measurement: Parkinson’s disease questionnaire 39 (PDQ 39) is 39 item questionnaire offers a patient reported measure of health status and quality of life. Scores are then transformed to a common range of 0 to 100 (100 = maximum level of problems). Lower score reflect better quality of life. Motor Symptoms. Timepoint: Baseline assessment i.e. before intervention (t0), after end of treatment sessions (t1) and after 3 months of intervention (t2). Method of measurement: Movement Disorder Society-Unified Parkinson's Disease Rating Scale Motor Examination Part (MDS-UPDRS III). Freezing of gait. Timepoint: Baseline assessment i.e. before intervention (t0), after end of treatment sessions (t1) and after 3 months of intervention (t2). Method of measurement: Freezing of gait questionnaire (FOGQ). Activities of daily living. Timepoint: Baseline assessment i.e. before intervention (t0), after end of treatment sessions (t1) and after 3 months of intervention (t2). Method of measurement: Barthel Index. The University of Lahore Approved 2019-03-01 Institutional Review Board of The University of Lahore 1-KM Defence Road, Off Bhobatian Chowk, Lahore Lahore Punjab Pakistan