Clinical trial NCT03548090: The Effects of Plantar Flexion Training in People With Chronic Stroke
Official title: The Effects of Plantar Flexion Training on Plantar Flexion Activation, Torque, and Step Length Asymmetry in People With Chronic Stroke
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Hemiplegic Gait
Keywords: stroke rehabilitation
walking limitations
gait rehabilitation
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: Texas Woman's University
First posted: 2018-06-07
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study consists of three phases that aim to develop an exercise intervention to promote maximal activation of ankle plantar flexors in the paretic lower extrimty (LE) in order to restore a more normalized gait pattern in chronic stroke survivors.

The aim of the first phase is to determine if there are differences between standing on different levels of inclination on plantar flexion activation during forward movement of the contralateral LE in adults with chronic with stroke.

The aim of second phase is to determine if there are differences between different percentages of weight bearing on the paretic LE on plantar flexion activation during forward movement of the contralateral LE in adults with chronic stroke.

The aim of the third phase is to determine if there are differences between a 4-week plantar flexion training intervention and conventional physical therapy.

Detailed description: Description of Arms:

This study has three phases. The first phase is performed in a cross-over fashion. Participants will stand on two different incline angles on the paretic LE and simultaneously move a small skateboard forward with the non-paretic LE. The testing order for the two different incline angles will be randomized, and all participants will be required to complete both incline angle conditions within a single test session.

The second phase will also be performed in a cross-over fashion. Participants will stand with three different percentages of body weight on their paretic LE while moving the skateboard forward with the non-paretic LE. The testing order for the three body weight percentages will be randomized. All participants will be required to complete all three body weight conditions within a single test session.

In the third phase, participants will be randomized to either a control 4-week exercise intervention (conventional physical therapy) or a 4-week experimental exercise intervention (plantar flexion training). Both the control and exerimental arms will complete over-ground multi-directional gait training and home exercise.

Eligibility criteria: Inclusion Criteria:

* Must be able to perform five times sit to stand test without the use of upper extremities
* Must have 10 degrees of passive ankle dorsiflexion measured in standing
* Must be able to walk with supervision level assistance with no assistive device

Exclusion criteria:

* Currently receiving physical therapy
* History of orthopedic ankle instability
* Lacking knee extension to neutral
* Unable to understand English
* Unable to follow multi-step commands
* History of orthopedic pathology that prevents completion of experimental condition
* Pain with weight bearing on paretic LE
* Received Botox to the plantar flexors within the last three months or phenol injections within the last six months
* Walk with a longer nonparetic step length than paretic step length

Primary outcomes:
measure: Step length asymmetry ratio as assessed by the GAITRite®
timeFrame: baseline, 6 weeks (relative to the phase 3 intervention)
measure: Muscle activity of the medial gastrocnemius as assessed by surface EMG
timeFrame: on the 1 day of the phase 1 intervention
measure: Muscle activity of the soleus as assessed by surface EMG
timeFrame: on the 1 day of the phase 1 intervention
measure: Plantar flexion torque as assessed by isokinetic dynamometry
timeFrame: baseline, 6 weeks (relative to the phase 3 intervention)
measure: Muscle activity of the medial gastrocnemius as assessed by surface EMG
timeFrame: on the 1 day of the phase 2 intervention
measure: Muscle activity of the soleus as assessed by surface EMG
timeFrame: on the 1 day of the phase 2 intervention
Secondary outcomes:
measure: Gait speed as assessed by the GAITRite®
timeFrame: baseline, 6 weeks (relative to the phase 3 intervention)
measure: Muscle activity of the medial gastrocnemius as assessed by surface EMG
timeFrame: baseline, 6 weeks (relative to the phase 3 intervention)
measure: Muscle activity of the soleus as assessed by surface EMG
timeFrame: baseline, 6 weeks (relative to the phase 3 intervention)
measure: Quality of life as assessed by the Stroke Impact Scale
timeFrame: baseline, 6 weeks (relative to the phase 3 intervention)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Daniel P Wingard, DPT
role: PRINCIPAL_INVESTIGATOR
References: