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

Primary Purpose

Chronic Stroke

Status

Unknown status

Phase

Not Applicable

Locations

Saudi Arabia

Study Type

Interventional

Intervention

Backward walking on sand

About this trial

This is an interventional treatment trial for Chronic Stroke focused on measuring Backward walking, stroke, gait training

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

King Khalid HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Group 1

Group 2

Group 3

Group 4

Arm Description

forward walking on leveled surface

forward walking on sand.

Backward walking on leveled surface

Backward walking on sand.

Outcomes

Primary Outcome Measures

Gait velocity (m/s)

Measured by Stride Analyser

Cadence (Number of steps per min)

Measured by stride Analyser

Stride length in meters

Measured by stride Analyser

Gait cycle in seconds

Measured by stride Analyser

Secondary Outcome Measures

Barthel index

ADL

Full Information

NCT ID

NCT03501186

First Posted

April 9, 2018

Last Updated

May 31, 2018

Sponsor

Majmaah University

1. Study Identification

Unique Protocol Identification Number

NCT03501186

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2018

Overall Recruitment Status

Unknown status

Study Start Date

January 12, 2017 (Actual)

Primary Completion Date

June 20, 2018 (Anticipated)

Study Completion Date

July 21, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Majmaah University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Stroke

Keywords

Backward walking, stroke, gait training

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

The treatment given by investigator unaware of allocation of patients and outcome variables measured by different investigator

Allocation

Randomized

Enrollment

20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Group 1

Arm Type

Experimental

Arm Description

forward walking on leveled surface

Arm Title

Group 2

Arm Type

Active Comparator

Arm Description

forward walking on sand.

Arm Title

Group 3

Arm Type

Experimental

Arm Description

Backward walking on leveled surface

Arm Title

Group 4

Arm Type

Active Comparator

Arm Description

Backward walking on sand.

Intervention Type

Other

Intervention Name(s)

Backward walking on sand

Other Intervention Name(s)

forward walking on sand

Intervention Description

the patient will be walking backwards on sand with therapist standing close to support in case of fall.

Primary Outcome Measure Information:

Title

Gait velocity (m/s)

Description

Measured by Stride Analyser

Time Frame

10-15 mins

Title

Cadence (Number of steps per min)

Description

Measured by stride Analyser

Time Frame

10-15 mins

Title

Stride length in meters

Description

Measured by stride Analyser

Time Frame

10-15 mins

Title

Gait cycle in seconds

Description

Measured by stride Analyser

Time Frame

10-15 mins

Secondary Outcome Measure Information:

Title

Barthel index

Description

ADL

Time Frame

45 Mins

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

King Khalid Hospital

City

Al Majma'ah

State/Province

Riyadh

ZIP/Postal Code

11952

Country

Saudi Arabia

Individual Site Status

Recruiting

Facility Contact: