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

Effects of Backward Gait on Sand on Improving the Gait Parameters of Patients With Chronic Stroke: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Chronic Stroke
• Intervention / Treatment: Other: Backward walking on sand

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Riyadh
    • Al Majma'ah, Riyadh, Saudi Arabia, 11952
      • Recruiting
      • King Khalid Hospital
      • Contact: faizan Z kashoo, Masters; Phone Number: 00966538149226; Email: f.kashoo@mu.edu.sa
      • Contact: shaik A Rahim, PhD; Phone Number: 00966534504703; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

4

Arms and Interventions

Participant Group / 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 Names: 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 Names: 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 Names: 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 Names: forward walking on sand

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Gait velocity (m/s)	Measured by Stride Analyser	10-15 mins
Cadence (Number of steps per min)	Measured by stride Analyser	10-15 mins
Stride length in meters	Measured by stride Analyser	10-15 mins
Gait cycle in seconds	Measured by stride Analyser	10-15 mins

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Barthel index	ADL	45 Mins

Collaborators and Investigators

• Sponsor: Majmaah University

Publications and helpful links

General Publications

• Makino M, Takami A, Oda A. Comparison of forward walking and backward walking in stroke hemiplegia patients focusing on the paretic side. J Phys Ther Sci. 2017 Feb;29(2):187-190. doi: 10.1589/jpts.29.187. Epub 2017 Feb 24.
• Kim CY, Lee JS, Kim HD. Comparison of the Effect of Lateral and Backward Walking Training on Walking Function in Patients with Poststroke Hemiplegia: A Pilot Randomized Controlled Trial. Am J Phys Med Rehabil. 2017 Feb;96(2):61-67. doi: 10.1097/PHM.0000000000000541.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 12, 2017
• Primary Completion (ANTICIPATED): June 20, 2018
• Study Completion (ANTICIPATED): July 21, 2018

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 16, 2018
• First Posted (ACTUAL): April 18, 2018

Study Record Updates

• Last Update Posted (ACTUAL): June 1, 2018
• Last Update Submitted That Met QC Criteria: May 31, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Backward walking, stroke, gait training
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Stroke
• Other Study ID Numbers: Majmaah

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Stroke Patients
• IPD Sharing Time Frame: 3 months
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No