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Effects of Backward Gait on Sand on Improving the Gait Parameters of Patients With Chronic Stroke.

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ClinicalTrials.gov Identifier: NCT03501186
Recruitment Status : Recruiting
First Posted : April 17, 2018
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
faizan kashoo, PT, Majmaah University

Brief Summary:
Gait training in stroke is a complex process of motor learning although restoring patients ability to walk would not prepare the individual with the challenges faced in the real environment. The aim is not simply walking in controlled environment, but to achieve dynamic walking. Dynamic walking is the ability of an individual to adjust to the changing surfaces and terrains. thereby returning to achieve active participation in the community. Hence, recovery of walking ability is the primary goal when planning treatment for patients with stroke.

Condition or disease Intervention/treatment Phase
Chronic Stroke Other: Backward walking on sand Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: The treatment given by investigator unaware of allocation of patients and outcome variables measured by different investigator
Primary Purpose: Treatment
Official Title: Effects of Backward Gait on Sand on Improving the Gait Parameters of Patients With Chronic Stroke: a Randomized Controlled Trial
Actual Study Start Date : January 12, 2017
Estimated Primary Completion Date : June 20, 2018
Estimated Study Completion Date : July 21, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group 1
forward walking on leveled surface
Other: Backward walking on sand
the patient will be walking backwards on sand with therapist standing close to support in case of fall.
Other Name: forward walking on sand

Active Comparator: Group 2
forward walking on sand.
Other: Backward walking on sand
the patient will be walking backwards on sand with therapist standing close to support in case of fall.
Other Name: forward walking on sand

Experimental: Group 3
Backward walking on leveled surface
Other: Backward walking on sand
the patient will be walking backwards on sand with therapist standing close to support in case of fall.
Other Name: forward walking on sand

Active Comparator: Group 4
Backward walking on sand.
Other: Backward walking on sand
the patient will be walking backwards on sand with therapist standing close to support in case of fall.
Other Name: forward walking on sand




Primary Outcome Measures :
  1. Gait velocity (m/s) [ Time Frame: 10-15 mins ]
    Measured by Stride Analyser

  2. Cadence (Number of steps per min) [ Time Frame: 10-15 mins ]
    Measured by stride Analyser

  3. Stride length in meters [ Time Frame: 10-15 mins ]
    Measured by stride Analyser

  4. Gait cycle in seconds [ Time Frame: 10-15 mins ]
    Measured by stride Analyser


Secondary Outcome Measures :
  1. Barthel index [ Time Frame: 45 Mins ]
    ADL



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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • Had experienced stroke for the first time.
  • Unilateral involvement.
  • Demonstrate motor stage 3 or 4 on Brunnstrom motor recovery.
  • Able to walk 12 m with or without assistive devices.
  • Medically stable.
  • Able to follow simple commands.

Exclusion criteria:

  • Patient exhibits comorbid disease other than stroke that may affect gait.
  • Any conditions contra indicated to exercises
  • Any other cardio-pulmonary or orthopedic disorders that affects walking ability of the participant.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03501186


Locations
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Saudi Arabia
King Khalid Hospital Recruiting
Al Majma'ah, Riyadh, Saudi Arabia, 11952
Contact: faizan Z kashoo, Masters    00966538149226    f.kashoo@mu.edu.sa   
Contact: shaik A Rahim, PhD    00966534504703    s.abdulrahim@mu.edu.sa   
Sub-Investigator: Faizan Z Kashoo, Masters         
Principal Investigator: Mazen M Alqahtani, PhD         
Sub-Investigator: Shaik A Rahim, PhD         
Sub-Investigator: Dana A Yahya, PhD         
Sub-Investigator: Abdulaziz Alkathiry, PhD         
Sponsors and Collaborators
Majmaah University

Publications:
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Responsible Party: faizan kashoo, PT, Faizan Kashoo, Master in physiotherapy, Majmaah University
ClinicalTrials.gov Identifier: NCT03501186     History of Changes
Other Study ID Numbers: Majmaah
First Posted: April 17, 2018    Key Record Dates
Last Update Posted: June 1, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Stroke Patients
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: 3 months

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by faizan kashoo, PT, Majmaah University:
Backward walking, stroke, gait training
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases