Effect of Adding Computerized Cognitive Training on Balance, Locomotion and Cognition in Parkinson's Disease

NCT06104072 | Recruiting

• 1 other identifier: P.T.REC/012/004746
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Parkinson Disease

Keywords

Computer-Based Cognitive training; Parkinsonian Disease; Postural Stability; Gait

Outcome Measures

Primary Outcomes (6)

• 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 * 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)

• 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)

Secondary Outcomes (1)

• Overall cognitive performance

  Baseline Assessment, Immediately Post Treatment, 3 Month Posttreatment Assessment (Follow-up)

Study Arms (2)

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

Other: A Designed Physical Therapy Program

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.

Device: REHACOM Software; Other: A Designed Physical Therapy Program

Interventions

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). * 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.

Also known as: Computer-Based Cognitive Training

Study group (GB)

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.

Control group (GA); Study group (GB)

Eligibility Criteria

• Age: 58 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Engy Badreldin Saleh Moustafa, PhD: lead

Study Sites (1)

Faculty of Physical Therapy, Cairo University

Giza, Giza Governorate, 11432, Egypt

RECRUITING

MeSH Terms

Conditions

Parkinson Disease; Parkinsonian Disorders

Condition Hierarchy (Ancestors)

Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Engy B Saleh, PhD

  Faculty of Physical Therapy, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Engy B Saleh, PhD

CONTACT

00201099445112; engybm.saleh@yahoo.com

Moshera H. Darwish, PhD

CONTACT

00201015163617; dr.moshera11@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Model Details: 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).

Study Record Dates

• First Submitted: October 20, 2023
• First Posted: October 27, 2023
• Study Start: May 23, 2024
• Primary Completion: February 13, 2025
• Study Completion: April 20, 2025
• Last Updated: April 9, 2025

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)