NCT04498429

Brief Summary

Physical therapists frequently use manual cueing as a tool to improve movement quality in persons recovering from stroke but evidence to support its effectiveness is lacking. The purpose of this graduate student research study is to determine the immediate and carryover effects of an integrated verbal and manual facilitation approach used by physical therapists during sit to stand training on the midline alignment, muscle activation and quality of movement in chronic stroke survivors with hemiplegia.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2020

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

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

First Submitted

Initial submission to the registry

July 28, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 4, 2020

Completed
3 months until next milestone

Study Start

First participant enrolled

November 6, 2020

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 24, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 24, 2022

Completed
Last Updated

February 2, 2024

Status Verified

February 1, 2024

Enrollment Period

1.8 years

First QC Date

July 28, 2020

Last Update Submit

February 1, 2024

Conditions

Keywords

FacilitationSit-to-StandManual CueingVerbal Cueing

Outcome Measures

Primary Outcomes (4)

  • Midline Orientation via Symmetry Ratio

    The participant's ability to equally distribute their weight throughout the sit to stand task will be measured via two force plates integrated with the Qualisys motion capture system. The ratio is calculated via dividing the weight on the hemiparetic leg by the weight on the non-hemiparetic side. A score of 1 indicates equal weight bearing.

    Baseline and immediately after the intervention

  • Midline Orientation via Trunk Lateral Lean angle

    The participant's ability to maintain an upright trunk throughout the sit to stand task as measured by computations from the Qualisys motion capture system using 40 trajectory markers. Perfect midline orientation would be a value of 0 degrees indicating midline orientation.

    Baseline and immediately after the intervention

  • Muscle Activation

    Comparison of muscle activation between normal and hemiparetic lower extremity extensor muscle groups as measured with surface electromyography (EMG) and processed through the Qualisys motion capture system. Change will be indicated by subtracting max contraction per various extensor muscle groups as a composite measure during the activity from initial max contraction of the same muscle group.

    During after the intervention

  • Time to complete Sit to Stand Activity

    A measurement of the total elapsed time to perform the sit to stand activity as measured from initial movement to highest position of center of mass

    Baseline and immediately after the intervention

Study Arms (2)

Integrated Manual and Verbal Cueing Group

EXPERIMENTAL

A series of 40 training repetitions of sit to stand using the Integrated/Manual Cueing intervention.

Other: Integrated Cueing Protocol

Verbal Cueing Group

EXPERIMENTAL

A series of 40 training repetitions of sit to stand using the Verbal Cueing intervention

Other: Verbal Cueing Protocol

Interventions

The first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. In addition to verbal cueing, the manual cueing group will receive hands-on tactile facilitation from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions.

Also known as: Manual Cueing Protocol
Integrated Manual and Verbal Cueing Group

The first 5 repetitions will include part to whole task practice of partial sit to stand using scripted verbal cueing to facilitate understanding of the task. The goal is to improve midline orientation and alignment during the task of moving from sitting to standing. The verbal cueing protocol consists of verbal cueing from a trained physical therapist to facilitate appropriate midline weight shift during the sit to stand activity for the series of 40 training repetitions.

Verbal Cueing Group

Eligibility Criteria

Age21 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Chronic Right CVA with left hemiplegia \> 6 Months
  • Able to ambulate with no more than help than supervision
  • Must be able to stand without an assistive device or ankle foot orthosis
  • Must be able to follow two-step verbal commands

You may not qualify if:

  • History of injury from a recent fall within the last 3 months
  • Currently participating in rehabilitation during the time frame of their participation in this study
  • Additional musculoskeletal or neurological conditions that may impair ability to perform sit to stand safely

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Loma Linda University Health

Loma Linda, California, 92350, United States

Location

Loma Linda University

Loma Linda, California, 92350, United States

Location

Study Officials

  • Eric G Johnson, DSc

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

July 28, 2020

First Posted

August 4, 2020

Study Start

November 6, 2020

Primary Completion

August 24, 2022

Study Completion

August 24, 2022

Last Updated

February 2, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

Individual data will not be shared

Locations