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Completed

NCT Number: NCT06109194

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

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.

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Key information

Conditions

Hemiparesis;Poststroke/CVA

Age range

21 year–86 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Loma Linda University Health

Loma Linda, California, 92350, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Joint Mobilization

Other

Grade III manual joint mobilization as standard-of-care physical therapy intervention

Other names: manual therapy, tissue stretch

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

Secondary outcomes

  1. 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'

Sponsors and collaborators

Lead sponsor

Loma Linda University

Other

Registry information

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 31, 2023
Registry last updated
Jan 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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