NCT05285241

Brief Summary

Stoke is a leading cause of disability that results not only in persistent neurological deficits but also profound physical de-conditioning that propagates stroke-related secondary disability. Several kinds of research have reported that there has been asymmetrical weight bearing on the affected side while sitting and standing resulting in impaired performance especially reaching in sitting, rising from the chair, walking, and climbing stairs. Despite the stroke patient being able to walk independently with or without the walking aids, the patient still lacks the normal movement pattern especially weight transfers on the affected side while performing such activities which subsequently decreases the patient to restrain the challenges while walking, decrease confidence in functional activities. Also, further, there hasn't been enough literature on this topic. Therefore, the objective of this study is to find out the effectiveness of multidirectional stepping and weight shifting exercises to improve dynamic balance and gait speed in stroke patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable stroke

Timeline
Completed

Started May 2016

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 22, 2017

Completed
4.8 years until next milestone

First Submitted

Initial submission to the registry

March 8, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 17, 2022

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

10 months

First QC Date

March 8, 2022

Last Update Submit

March 17, 2022

Conditions

Keywords

StrokeBalanceGaitBerg balance scaleFunctional gait assessment

Outcome Measures

Primary Outcomes (2)

  • Berg Balance Scale

    The Berg Balance Scale (BBS) is used to objectively determine a patient's ability (or inability) to safely balance during a series of predetermined tasks. It is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. Minimum possible value is 0 and maximum possible value is 56. Higher score represents better outcome.

    4 weeks.

  • Functional gait assessment

    The Functional Gait Assessment (FGA) assesses postural stability during walking tasks in persons with gait impairments.

    4 weeks.

Study Arms (2)

Multidirectional exercise group

EXPERIMENTAL

Multidirectional stepping exercises along with conventional physiotherapy were provided to the patients. Conventional physiotherapy included one-to-one range of motion exercises (10min), Strengthening exercises (10 min), Functional mat exercises (10 min), Stretching exercises (5 min), and Gait exercises (10 min).

Other: Multidirectional stepping exercises

Conventional Physiotherapy Group

ACTIVE COMPARATOR

One-to-one range of motion exercises (10min), Strengthening exercises (10 min), Functional mat exercises (10 min), Stretching exercises (5 min), and Gait exercises (10 min) were provided to the patients.

Other: Conventional physiotherapy group

Interventions

These exercises included stepping of the legs in different directions i.e. sideways, sideways and forefoot (forward), sideways and heel (backward).

Multidirectional exercise group

Conventional physiotherapy included a one-to-one range of motion exercises (10min), Strengthening exercises (10 min), Functional mat exercises (10 min), Stretching exercises (5 min), and Gait exercises (10 min)

Conventional Physiotherapy Group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with stroke via CT Scan or MRI
  • Maintain the independent standing posture for 30 sec
  • Ability to walk 3 meters independently without an assistive device
  • Mini-Mental status examination score \>21 points
  • Could communicate and understand therapist's verbal command
  • Voluntary agreed to participate in the study
  • Age above 18 years old
  • Medically stable (e.g. recent myocardial infarction, unstable angina, ventricular tachycardia)

You may not qualify if:

  • Visual disorders and visual deficits
  • History of any neurological pathology like Parkinson's or Alzheimer's disease
  • Conditions affecting balance like vertigo
  • Medications affecting balance
  • Dementia
  • Impaired conscious level or concomitant medical illness
  • Lower Motor Neuron lesions
  • Anti-spasmodic medication (e.g. Baclofen, Dantrolene Sodium, etc.)
  • Severe orthopedic diseases in lower extremities (e.g. Osteoarthritis, fracture, sprain, strain)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King Saud University

Riyadh, 11433, Saudi Arabia

Location

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Officials

  • Masood Khan, M.P.Th

    King Saud University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Two arms parallel design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 8, 2022

First Posted

March 17, 2022

Study Start

May 11, 2016

Primary Completion

March 14, 2017

Study Completion

May 22, 2017

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations