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BACKGROUND: Postural instability and gait abnormalities are cardinal features 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 immediate and long-term effects of adding computer-based cognitive training to physical therapy interventions on postural stability, locomotion, and cognitive performance in Parkinson's disease patients.
Study design: A randomized control clinical trial among sixty-eight Egyptian Parkinson's Disease patients of both sexes participated in the study; their ages ranged from 55 to 70 years. They were selected from the Neurology Clinics and from the Movement Disorder Clinic, Neurology Department, Faculty of Medicine, Cairo University, in the period from May 2024 to March 2025.
The patients will be divided into two equal groups: the control group (GA) and the study group (GB). Patients in GA will be treated by a designed physiotherapy program consisting of aerobic exercise on a treadmill, stretching exercises, proprioceptive neuromuscular facilitation (PNF) techniques, graduated active exercises, gait training, reciprocal, and weight-shifting exercises for 60 minutes. Patients in (GB) will be treated with computer-based cognitive training using REHACOM (30 minutes) in addition to the same physiotherapy program as GA (30 minutes). Rehacom software will be used for cognitive training targeting four main cognitive domains; attention/concentration, figural memory, auditory response control, and visual response control. . The treatment session for all patients in both groups will be 60minutes/session. The whole treatment protocol will include 24 sessions, three sessions per week, for two successive months.
Primary Outcomes:
Postural stability:
- Biodex balance system was used to assess dynamic balance indices ( Overall stability index, mediolateral stability & anteroposterior stability)
Spatio-temporal gait parameters:
Secondary Outcome:
a. Overall cognitive functions:
- Parkinson's Disease - Cognitive Rating Scale (PD-CRS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group (GA) | Placebo Comparator | Patients in control group (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 for 60 minutes/session, 3 days/week for 8 consecutive weeks |
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| Study group (GB) | Experimental | Patients in (GB) will be treated by computer-based cognitive training for 30 minutes followed by the same physiotherapy program as GA for another 30 minutes. so the whole duration of the treatment session for (GB) is 60 minutes ( half of the session the computerized cognitive training and the other half is for the designed physical therapy program). the whole treatment intervention will be 3 days /week for 8 consecutive weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REHACOM Software | Device | 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).
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| Measure | Description | Time Frame |
|---|---|---|
| Overall 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) |
| Velocity of Gait | Using 2D motion analysis in Kinovea program for spatiotemporal gait analysis o Velocity = Distance/Time
| 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
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| Measure | Description | Time Frame |
|---|---|---|
| Overall cognitive performance |
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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Engy B Saleh, PhD | Contact | 00201099445112 | engybm.saleh@yahoo.com | |
| Moshera H. Darwish, PhD | Contact | 00201015163617 | dr.moshera11@yahoo.com |
| Name | Affiliation | Role |
|---|---|---|
| Engy B Saleh, PhD | Faculty of Physical Therapy, Cairo University, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Physical Therapy, Cairo University | Recruiting | Giza | Giza Governorate | 11432 | Egypt |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D020734 | Parkinsonian Disorders |
| ID | Term |
|---|---|
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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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 for 60 minutes/session. Patients in (GB) will be treated by computer-based cognitive training (30 minutes) in addition to the same physiotherapy program as GA (30 minutes).
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Patients participated will be masked about the type of intervention, where (GA) patients will receive PT program for 60 minutes, while patients in (GB) will receive computer -based REHACOM cognitive training (30 minutes) in addition to the same PT program as (GA)(30 minutes).
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| A Designed Physical Therapy Program | Other | A designed physiotherapy program consisted of aerobic exercise on treadmill, stretching exercise, Proprioceptive neuromuscular facilitation (PNF) techniques, Graduated active exercises, postural correction, gait training, balance training on different base of supports using static and dynamic balance training with reciprocal and weight shifting exercises. |
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| Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up) |
| Stride Length | Using 2D motion analysis in Kinovea program, stride length was the distance from the first initial contact of one foot (1st frame) to the next initial contact of the ipsilateral foot (2nd frame). | Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up) |
| Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up) |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |