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

Sponsor
Loma Linda University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06109194
Collaborator
(none)
20
1
1
12
1.7

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Joint mobilization
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
pre-test, intervention, post-testpre-test, intervention, post-test
Masking:
None (Open Label)
Masking Description:
No masking to occur
Primary Purpose:
Treatment
Official Title:
Immediate Effect of Ankle Mobilization on Active Range of Motion and Gait in Subacute Stroke
Anticipated Study Start Date :
Dec 1, 2023
Anticipated Primary Completion Date :
Dec 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Active range of motion of the paretic ankle [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.

    2. Gait characteristic of: velocity [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.

    3. Gait characteristic of: stride length [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.

    4. Gait characteristic of: second double-limb stance time [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.

    5. Gait characteristic of: stride length symmetry [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.

    6. Gait characteristic of: second double limb stance symmetry [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.

    Secondary Outcome Measures

    1. Subjective rating of perceived ability to walk [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'

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    21 Years to 86 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Loma Linda University Health Loma Linda California United States 92350

    Sponsors and Collaborators

    • Loma Linda University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Eric Johnson, Professor Physical Therapy, Loma Linda University
    ClinicalTrials.gov Identifier:
    NCT06109194
    Other Study ID Numbers:
    • 5230164
    First Posted:
    Oct 31, 2023
    Last Update Posted:
    Oct 31, 2023
    Last Verified:
    Oct 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Eric Johnson, Professor Physical Therapy, Loma Linda University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 31, 2023