NCT03788629

Brief Summary

Adequate ankle motion for normal gait ranges from 10° to 15° of dorsiflexion passive range of motion (DF-PROM) to allow the tibia to move over the talus. However, limited ankle mobility is a common impairment in patients with stroke whose DF-PROM has been shown to be approximately half of that in healthy subjects. As a result, these patients have impaired dynamic balance in standing or gait. Mulligan first proposed mobilization with movement (MWM) as a joint mobilization technique. Talocrural MWM to facilitate DF-ROM is performed by applying a posteroanterior tibia glide over a fixed talus while the patient actively moves into a dorsiflexed position while standing. Talocrural MWM has been applied to chronic ankle instability and has been proven effective in improving DF-PROM and standing balance. Subtalar MWM to facilitate DF-ROM is performed by bringing foot to dorsiflexion-abduction-eversion by flexing patient' knee. The effects of subtalar MWM have not been investigated in patients with stroke. Therefore, the purpose of the present study is to examine the effects of subtalar MWM on muscle strength, balance, functional performance, and gait parameters in patients with chronic stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

June 30, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2018

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 25, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 27, 2018

Completed
Last Updated

April 7, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

December 25, 2018

Last Update Submit

April 5, 2020

Conditions

Keywords

hemiplegiafootmobilization

Outcome Measures

Primary Outcomes (1)

  • Isokinetic Strength Dynamometer

    Maximal concentric contraction was measured for the dorsiflexors and plantarflexors using an isokinetic dynamometer (Biodex System Pro 4 Isokinetic Strength Dynamomter , Inc., Shirley, NY). The participants were seated with the ankle joint axis aligned.with the mechanical axis of the dynamometer. A performed practice trial to familiarize themselves with the test protocol, the participants were instructed to push and pull the attachment as hard and as fast as possible. Five maximum concentric contractions were performed at 30°/s and the peak torque generated over 5 repetitions was recorded and normalized to body weight (Nm/kg).

    6 weeks

Secondary Outcomes (3)

  • Timed up and Go Test

    6 weeks

  • Berg Balance Scale

    6 weeks

  • Biodex Gait Trainer Treadmill System (BGTTS)

    6 weeks

Study Arms (2)

Study Group 1

EXPERIMENTAL

Bobath Concept+ Talocrural joint Mulligan MWM techniques were applied to this group.

Other: Talocrural joint MWM mobilization

Study Group 2

ACTIVE COMPARATOR

Subtalar joint Mulligan MWM techniques were applied to this group in addition to Bobath Concept+ Talocrural joint Mulligan MWM techniques

Other: Subtalar joint MWM mobilization

Interventions

There were two groups for this study. In addition to Bobath Concept, talocrural joint mobilization was performed.

Study Group 1

There were two groups for this study. In addition to treatment of control group, subtalar joint mobilization was performed.

Study Group 2

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • hemiplegic stroke (\>6 months post stroke),
  • ability to perform a single-leg lunge on the paretic lower limb onto a stool from a standing position,
  • ability to walk without an assistive device for more than 10 m,
  • limited dorsiflexion passive ROM with contracture of the paretic ankle, and capability of following simple verbal instructions.

You may not qualify if:

  • visual impairment,
  • unilateral neglect,
  • aphasia.
  • contraindications for joint mobilization (i.e., ankle joint hypermobility, trauma, or inflammation),
  • ankle sprain in the previous 6 weeks,
  • any history of ankle surgery,
  • and those concurrently receiving similar interventions outside of the present study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Caner KARARTI

Kırşehir, 40100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hemiplegia

Condition Hierarchy (Ancestors)

ParalysisNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
Single blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Caner Karartı, Hacettepe University

Study Record Dates

First Submitted

December 25, 2018

First Posted

December 27, 2018

Study Start

June 30, 2018

Primary Completion

August 20, 2018

Study Completion

September 20, 2018

Last Updated

April 7, 2020

Record last verified: 2020-04

Locations