Effect of Adding Computerized Cognitive Training on Balance and Gait in Parkinson's Disease (Follow-up Study)

Study Overview
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Brief Summary
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BACKGROUND: Postural instability is one of the cardinal signs in Parkinson's disease (PD). It represents one of the most disabling symptoms in the advanced stages of the disease. The purpose of this study was to evaluate the Long term effect of adding computer- based cognitive training to physical Therapy intervention on postural stability and gait performance in Parkinson's disease Patients.

Detailed Description
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Study design: Randomized control clinical trial among Thirty Egyptian Parkinson's Disease patients of both sex participated in the study, their age range from 55 to 68 years. They were selected from the Neurology Clinics and from Movement disorder clinic, Neurology Department, Faculty of Medicine, Cairo University in the period from September 2023 to January 2024. The patients will be divided into two equal groups; control group (GA) and study group (GB). Patients in (GA) will be treated by a designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, gait training, Reciprocal and weight shifting exercises in addition to sham computerized cognitive training. Patients in (GB) will be treated by computer-based cognitive training in addition to the same physiotherapy program as GA. The treatment will be conducted three sessions per week, day after day for successive four weeks. Assessment of motor performance: Biodex balance system was used to assess dynamic balance indices and dynamic limit of stability. Digital video camera and kinovea (video motion analysis software) were used to assess spatiotemporal gait parameters. Assessment of cognitive functions: - Parkinson's Disease - Cognitive Rating Scale (PD-CRS). Computer-Based cognitive training using Rehacom software: Patients in study group (GB) will receive cognitive training using the Rehacom software. The cognitive domains that will be included in the treatment sessions include : Attention/Concentration , Reaction Behavior and Figural Memory.

Official Title
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Long Term Effect of Adding Computer- Based Cognitive Training to Physical Therapy Intervention on Postural Stability and Gait Performance in Parkinson's Disease Patients

Conditions
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Parkinson Disease

Intervention / Treatment
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* Device: REHACOM Software
* Other: Designed Physical Therapy Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Egyptian Parkinson's Disease patients of both sex , all patients fulfilled the U.K Parkinson's Disease Brain Bank Criteria for diagnosis of idiopathic PD. The patients' age ranged from 58 to 68 years. The duration of illness ranged from two to five years. The severity of the disease ranged from mild to moderate disability according to UPDRS motor scores (part III) and Modified Hoehn and Yahr staging (stage 2.5&3) . Cognitive function ranged from 65 to 81 according to Parkinson's Disease-Cognitive Rating Scale (PD-CRS) that indicates mild cognitive impairment. The patients with mild balance and gait impairments Medically and psychologically stable patients and of adequate cardiac function to adhere to the protocol. Exclusion Criteria: Patients with secondary parkinsonism (Drug-induced, post traumatic, or post infectious) or atypical parkinsonism. Patients with major language disturbance, severe physical, auditory or visual impairment affecting their ability to complete testing. Patients with magnetic devices or any other implanted device (e.g., metallic implants such as pacemakers, surgical aneurysm clips…etc). Patients with a history of seizure, head injury or brain surgery. Complicating or unstable cardiovascular disease (unstable angina, recent myocardial infarction within the last three months, congestive heart failure, significant heart valve dysfunction, or unstable hypertension) or pulmonary disorders. Patients with musculoskeletal disorders such as severe arthritis, knee surgery, total hip joint replacement, lower limb fractures or contractures of fixed deformity. Patients with evidence from the history, physical examination, or special investigations for any concomitant medical or metabolic illness known to affect cognition e.g. cerebrovascular stroke, thyroid or parathyroid disease, hepatic or renal failure. Patients receiving certain drugs known to improve cognition (e.g. rivastigmine, memantine…..etc). Patients with current or prior history of major psychiatric disorder and/or current use of anxiolytic, neuroleptic, sedative medication or sleeping aids. Uncooperative patients. Illiterate patients.

Ages Eligible for Study
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Minimum Age: 58 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized Controlled Clinical trial, where the recruited patients will be randomly assigned into 2 equal groups ( GA & GB) using sealed envelopes. control group (GA) and study group (GB). Patients in (GA) will be treated by a designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, gait training, Reciprocal and weight shifting exercises in addition to sham computerized cognitive training. Patients in (GB) will be treated by computer-based cognitive training in addition to the same physiotherapy program as GA.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group (GA)<br>control group (GA) and study group (GB). Patients in (GA) will be treated by a designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, gait training, Reciprocal and weight shifting exercises in addition to sham computerized cognitive training. | Other: Designed Physical Therapy Program<br>* a designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, gait training, Reciprocal and weight shifting exercises.<br>|
| Experimental: Study group (GB)<br>Patients in (GB) will be treated by computer-based cognitive training in addition to the same physiotherapy program as GA. | Device: REHACOM Software<br>* It is a computer-based cognitive rehabilitation test that includes 32 cognition training tasks for attention/concentration, reaction behavior, memory , logical reasoning & executive functioning with graded difficulty . It is composed of regular PC , 1G RAM , DVD drive, 100 GB hard drive with windows XP SP3, 128 MB RAM direct 3D graphic card , Screen at least 19 , regular PC keyboard or Rehacom panel & printer .The Rehacom software version is (patientenpult (1990-1997) EN/ISO-13485-certified). For each Cognitive training domain there is one hundred levels of difficulty. Each patient is evaluated from level one(1) ang gradually increase the difficulty till we reach the level that will be used in the treatment sessions as the patient's performance improve we can proceed to the next level. The period of the session was chosen to be maximum (60 minutes) for each patient with five minutes rest in between each level.<br>* Other names: Computer-Based Cognitive Training;Other: Designed Physical Therapy Program<br>* a designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, gait training, Reciprocal and weight shifting exercises.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall balance index (Stability Index) | o Overall balance index: represents the patient's ability to control balance in all directions. High values indicate balance disturbance (increase rate of body swaying during the test). | Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up) | 
| Anterior / posterior (A/P) index | o Anterior / posterior (A/P) index represents the patient's ability to control balance in front to back direction. | Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up) | 
| Medial/ lateral (M/L) index | o Medial/ lateral (M/L) index: represents the patient's ability to maintain balance from side to side. | Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up) | 
| Directional Control Score in the dynamic limits of stability (LOS) test | Biodex balance system was adjusted for LOS test. The test difficulty was set at the easy level. - The LOS test screen displayed eight boxes arranged around a central box in eight directions (forward, backward, forward-right, backward-left, right, left, backward-right and forward-left); - The instrument recorded and calculated the shortest vertical or horizontal path to reach the target from the center in each direction which was expressed as the directional control score. The directional control which is a comparison of the amount of movement in the intended direction (toward the target) to the amount of extraneous movement (away from target). Directional control=(Amount of intended movement-Amount of extraneous movement)/(Amount of intended movement). It was expressed as a percentage. | Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up) | 
| Dynamic limits of stability (LOS) Total Test Time | Overall Time elapsed to complete the dynamic limits of stability test in seconds. | Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up) | 
| Velocity of Gait | Using 2D motion Analysis in Kinovea program for spatiotemporal gait analysis o Velocity = Distance/Time The total distance: represented by the actual length that the patient walked and this was presented by the blue line (three meters). The total duration of walking (seconds): was calculated by using the ''stop watch'' tool in kinovea program. Velocity meter/seconds: was calculated by dividing the total distance that had been walked by the patient over the total duration. | Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up) | 
| Cadence of Gait | Using 2D motion Analysis in Kinovea program for spatiotemporal gait analysis Cadence is the Number of steps/Minute Number of steps: calculated by counting the steps the patient walked from the beginning to the end of the walkway (blue line). Cadence was calculated by dividing the number of steps that the patient walked over the actual duration of walking. | Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up) | 
| Parkinson's Disease - Cognitive Rating Scale (PD-CRS) | Parkinson's Disease - Cognitive Rating Scale (PD-CRS) was conducted for each patient from a comfortable sitting position on a chair with back support and suitable seat height compared to a table in front of the patient. The following cognitive domains were assessed: - Immediate free recall verbal memory (12 points), Confrontation naming (20 points), - Sustained attention (ten points), Working memory (ten points), - Visuo-constructional skills (Unprompted drawing of a clock) (ten points), Visuo-perceptual skills (Copy drawing of a clock) (ten points), - Delayed free recall verbal memory (12 points),Alternating verbal fluency (20 points) and - Action verbal fluency (30 points). The overall total score for the (PD-CRS) is 134, the lower the score the more the cognitive impairment. The inclusion criteria for PD patients with cognitive decline indicated that a score 65-84 was the optimal cutoff point on the total score for the PD-CRS indicating mild cognitive impairment. | Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Computer-Based Cognitive training, Parkinsonian Disease, Postural Stability, Gait