NCT03501186

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2017

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 12, 2017

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 21, 2018

Completed
Last Updated

June 1, 2018

Status Verified

May 1, 2018

Enrollment Period

1.4 years

First QC Date

April 9, 2018

Last Update Submit

May 31, 2018

Conditions

Chronic Stroke

Keywords

Backward walking, stroke, gait training

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (1)

  • Barthel index

    45 Mins

Study Arms (4)

Group 1

EXPERIMENTAL

forward walking on leveled surface

Other: Backward walking on sand

Group 2

ACTIVE COMPARATOR

forward walking on sand.

Other: Backward walking on sand

Group 3

EXPERIMENTAL

Backward walking on leveled surface

Other: Backward walking on sand

Group 4

ACTIVE COMPARATOR

Backward walking on sand.

Other: Backward walking on sand

Interventions

Backward walking on sandOTHER

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

Also known as: forward walking on sand
Group 1Group 2Group 3Group 4

Eligibility Criteria

Age45 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Khalid Hospital

Al Majma'ah, Riyadh Region, 11952, Saudi Arabia

RECRUITING

Related Publications (2)

  • 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.

    PMID: 28265136BACKGROUND

  • 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.

    PMID: 27323323BACKGROUND

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The treatment given by investigator unaware of allocation of patients and outcome variables measured by different investigator
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Faizan Kashoo, Master in physiotherapy

Study Record Dates

First Submitted

April 9, 2018

First Posted

April 18, 2018

Study Start

January 12, 2017

Primary Completion

June 20, 2018

Study Completion

July 21, 2018

Last Updated

June 1, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will share

Stroke Patients

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
Time Frame
3 months

Locations

SA(1)