Immediate Effect of Ankle Mobilization on Active Range of Motion and Gait in Subacute Stroke

January 2, 2025 updated by: Loma Linda University

The goal of this observational study is to determine the effect of ankle joint mobilization on active range of motion and gait in subacute first-time stroke. The main questions it aims to answer are:

  • What is the effect of ankle joint mobilization on active range of motion in the ankle and gait qualities?
  • What is the effect of ankle joint mobilization on self-perceived gait ability?

Participants will receive physical therapy interventions of:

  • Grade III ankle joint mobilization
  • stretching of ankle plantarflexor muscles
  • ankle muscle activation training
  • assisted gait as part of assessment

Study design is to measure conditions before and after the intervention to determine effect(s) of one treatment dose, completed within one session of 90 minutes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Initial passive and active ankle range of motion measured by goniometer. Initial gait quality will be measured by walking with splinting for frontal plane ankle stability if indicated, assistive device for body weight support if needed, and manual assistance from an experienced physical therapist, on a Zeno Walkway pressure-sensitive mat for five complete stride cycles, taking 3 to 5 minutes. Data collected from the mat will be electronically captured using ProtoKinetics software. Participant initial self-rated perception of ability to walk will be marked on a 0-10 scale, on paper. Treatment intervention follows. With participant lying on the back, paretic ankle moderate-force grade III anterior to posterior-directed manual joint mobilizations will be performed by therapist; three sets of fifteen oscillations. Ankle plantarflexor muscles will be stretched for 75 seconds in supported standing. Ankle dorsiflexion muscle activation training will be performed for three minutes while in a seated position. Post-intervention measurements will proceed in the same sequence as initial measurements listed above: Ankle passive and active range of motion and walking ability will be reassessed, and self-perceived ability to walk will be rated again.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Loma Linda, California, United States, 92350
        • Loma Linda University Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • First stroke
  • subacute phase after stroke
  • able to follow one-step commands
  • paretic passive ankle dorsiflexion less than 5 degrees

Exclusion Criteria: referring to paretic ankle;

  • ankle pain of undetermined cause at rest
  • fracture in paretic lower extremity
  • muscle or ligament tear
  • recent ankle sprain
  • skin tear or wound
  • joint fusion or implanted hardware

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Pre-assessment of active and passive range of motion in the paretic ankle, and five strides of gait assessment on a pressure-sensitive mat. Intervention will be moderate grade III anterior-to-posterior directed ankle mobilization for 2 minutes while supine, ankle muscle stretch for 75 seconds in standing, ankle muscle training for 3 minutes while seated. Post-assessment is repeated in the same sequence and content as pre-assessment.
Other: Joint mobilization
Grade III manual joint mobilization as standard-of-care physical therapy intervention
Other Names:
  • manual therapy, tissue stretch

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active range of motion of the paretic ankle
Time Frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
ankle (talocrural) joint dorsiflexion movement of the foot away from plantarflexion end-range, measured by goniometry in seated position, by a physical therapist with 25 years' experience. Normal ankle ranges are 0 to 45 degrees from neutral for plantarflexion and 0-25 degrees from neutral for dorsiflexion. 0 to 15 degrees of dorsiflexion is needed for functionally efficient gait. Both passive and active ankle dorsiflexion range of motion are expected to increase, but be less than normal.
Change between baseline assessment and post-intervention assessment, immediately following intervention
Gait characteristic of: velocity
Time Frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
distance and time measurement captured as participant walks over a pressure-sensing mat. Data is processed with ProtoKinetics software. Velocity in meters per second is determined, and compared to normative values for non-stroke males (1.37 m/sec) and females (1.30 m/sec), and in relation to meaningful change in walking speed in in-patient stroke (0.13 m/sec). Velocity is anticipated to increase from pre- to post-intervention, but still be less than normal.
Change between baseline assessment and post-intervention assessment, immediately following intervention
Gait characteristic of: stride length
Time Frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
distance from foot contact to same foot contact measurement in meters captured as participant walks over a pressure-sensing mat. Data is processed with ProtoKinetics software. Findings will be compared to normative values for non-stroke males (1.51m) and females (1.32 m). Distance is hypothesized to increase post-intervention, but not approximate normal distance.
Change between baseline assessment and post-intervention assessment, immediately following intervention
Gait characteristic of: second double-limb stance time
Time Frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
Time measurement of the second occurrence when both feet are in contact with the ground, with reference to the paretic lower extremity. This will be compared to the normative value in adults of 0.12 second, and is hypothesized to be of lower duration post-intervention compared to pre-intervention, but still longer than normal.
Change between baseline assessment and post-intervention assessment, immediately following intervention
Gait characteristic of: stride length symmetry
Time Frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
distance from foot contact to same foot contact measurement in meters captured for each foot as participant walks over a pressure-sensing mat. Data is processed with ProtoKinetics software. Normal gait stride length is symmetrical for adults, and is hypothesized to improve from pre- to post-intervention measurement.
Change between baseline assessment and post-intervention assessment, immediately following intervention
Gait characteristic of: second double limb stance symmetry
Time Frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
Time measurement of the second occurrence when both feet are in contact with the ground. Times with reference to left and right lower extremity will be compared for symmetry. It is hypothesized that second double limb stance time will improve toward symmetry from pre- to post-intervention measurement.
Change between baseline assessment and post-intervention assessment, immediately following intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Subjective rating of perceived ability to walk
Time Frame: Change between baseline assessment and post-intervention assessment, immediately following intervention
Participant marks on paper self-perception of walking ability, responding to the instruction: 'please circle a point on the scale that shows level of confidence in walking a few steps unassisted on any household surface at this time. Where 0 = not at all confident and 10 = very confident'
Change between baseline assessment and post-intervention assessment, immediately following intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loma Linda University

Investigators

  • Study Chair: Eric G Johnson, PT, DSc, Loma Linda University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 19, 2023

Primary Completion (Actual)

June 10, 2024

Study Completion (Actual)

June 10, 2024

Study Registration Dates

First Submitted

October 25, 2023

First Submitted That Met QC Criteria

October 25, 2023

First Posted (Actual)

October 31, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 2, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 5230164

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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