Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000786392
Ethics application status
Approved
Date submitted
4/05/2017
Date registered
29/05/2017
Date last updated
29/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
The Effects of Neuromuscular Electrical Stimulation on Ankle Control and Gait Performance in Individuals with Chronic Stroke
Scientific title
The Effects of Neuromuscular Electrical Stimulation on Ankle Control and Gait Performance in Individuals with Chronic Stroke: A Randomized Controlled Trial
Secondary ID [1] 291849 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 303098 0
Condition category
Condition code
Physical Medicine / Rehabilitation 302557 302557 0 0
Physiotherapy
Stroke 302558 302558 0 0
Haemorrhagic
Stroke 302559 302559 0 0
Ischaemic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Stroke individuals with inadequate ankle control were recruited and randomized to three groups: neuromuscular electrical stimulation on tibialis anterior muscle (NMES-TA), neuromuscular electrical stimulation on medial gastrocnemius muscle (NMES-MG), and control group.
Participants in both NMES groups received 20 minutes NMES on either tibialis anterior (NMES-TA) or gastrocnemius (NMES-MG) followed by 15 minutes of ambulation training 3 times per week for 7 weeks. The NMES was triggered by electromyographic biofeedback devices. The participants were asked to actively dorsiflex (NMES-TA) or plantarflex (NMES-GA group) to reach the training goal to activate the electrical stimulation. After participants completed 5 cycles of active ankle dorsiflexion or plantarflexion successfully, the training goal was increased by 2 uV progressively and lasted for 20 minutes.
Participants in control group received general exercises for 20 minutes, including stretching for 5 minutes and range of motion exercises for 15 minutes, followed by 15 minutes of ambulation training 3 times per week for 7 weeks.
The ambulation training was focused on ankle movement and ankle control. While the participant was walking, a physiotherapist provided verbal cues and immediate corrections when necessary to improve participant’s gait performance. All trainings were instructed by a physiotherapist with individual one-on-one sessions at the training center in National Yang Ming University.
Intervention code [1] 297958 0
Rehabilitation
Intervention code [2] 297959 0
Treatment: Other
Intervention code [3] 298087 0
Treatment: Devices
Comparator / control treatment
Control group received general exercises for 20 minutes, including stretching for 5 minutes and range of motion exercises for 15 minutes, followed by 15 minutes of ambulation training 3 times per week for 7 weeks.
Control group
Active

Outcomes
Primary outcome [1] 301978 0
ankle range of motion measured by twin-axis electronic goniometer at heel strike and push off during gait
Timepoint [1] 301978 0
before intervention and after 7 weeks of intervention
Primary outcome [2] 301980 0
spatial-temporal parameters of gait obtained from the GAITRite system
Timepoint [2] 301980 0
before intervention and after7 weeks of intervention
Secondary outcome [1] 334429 0
isometric muscle strength of ankle dorsiflexor and plantarflexor of the affected limb measured by handheld dynamometer
Timepoint [1] 334429 0
before intervention and after 7 weeks of intervention
Secondary outcome [2] 334430 0
electromyographic (EMG) activities of ankle dorsiflexor and plantarflexor of the affected limb measured by bipolar Ag-AgCl electrodes during gait
Timepoint [2] 334430 0
before intervention and after 7 weeks of intervention
Secondary outcome [3] 334431 0
Dynamic spasticity of ankle plantarflexors in stance phase during gait using the method proposed by Lamontagne et al. in 2001.
Timepoint [3] 334431 0
before intervention and after 7 weeks of intervention
Secondary outcome [4] 334432 0
static spasticity of ankle plantarflexors measured by Modified Ashworth Scale in supine position
Timepoint [4] 334432 0
before intervention and after 7 weeks of intervention

Eligibility
Key inclusion criteria
The inclusion criteria were (1) first stroke at least 6 months ago, (2) with passive range of motion of ankle dorsiflexion at least to neural position (neutral position is defined as 0 degree), (3) with inadequate ankle control during gait (dorsiflexion less than -5 degree at heel strike and plantarflexion less than 10 degree at push off), (4) ability to walk at least 10 m with or without assistive devices, and (5) a detectable surface Electromyographic signal (>5 microvolt) from the TA and medial gastrocnemius (MG) of the affected leg
Minimum age
20 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
The exclusion criteria were (1) sensory loss, (2) insufficient cognition (Mini-Mental State
Examination < 24) and communication function, (3) contraindications to Neuromuscular electrical stimulation such as a pacemaker and tumor, (4) other orthopedic and neurologic disorders affecting walking functions.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The SPSS software (SPSS Inc., USA) was used for data analysis. The demographic and baseline data were compared among three groups using Kruskal-Wallis test. The Wilcoxon signed-rank test was used for within-group comparisons.

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
Actual
20/08/2013
Date of last participant enrolment
Anticipated
Actual
2/05/2014
Date of last data collection
Anticipated
Actual
24/06/2014
Sample size
Target
45
Accrual to date
Final
25
Recruitment outside Australia
Country [1] 8873 0
Taiwan, Province Of China
State/province [1] 8873 0

Funding & Sponsors
Funding source category [1] 296347 0
Government body
Name [1] 296347 0
Ministry of Science and Technology
Country [1] 296347 0
Taiwan, Province Of China
Primary sponsor type
University
Name
National Yang-Ming University
Address
No. 155, Li-Nong Street Section 2, Pei-Tou District, Taipei, Taiwan 112
Country
Taiwan, Province Of China
Secondary sponsor category [1] 295298 0
None
Name [1] 295298 0
Address [1] 295298 0
Country [1] 295298 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297579 0
Taipei Veterans General Hospital
Ethics committee address [1] 297579 0
No.201, Sec. 2, Shipai Rd., Beitou District, Taipei City, Taiwan 11217
Ethics committee country [1] 297579 0
Taiwan, Province Of China
Date submitted for ethics approval [1] 297579 0
Approval date [1] 297579 0
19/07/2013
Ethics approval number [1] 297579 0
2013-07-028B

Summary
Brief summary
Walking dysfunction is a major problem leading to physical disability even after rehabilitation in stoke. Decreased gait speed and asymmetric gait pattern are common gait deficits resulted from spasticity, muscle weakness and poor motor control, especially in ankle joint. There are many strategies focused on the improvement of ankle control in the stroke rehabilitation. Neuromuscular electrical stimulation (NMES) is one possible treatment strategy, which is commonly used in clinic. Previous studies suggested that NMES not only improved muscle strength but also decreased static spasticity through reciprocal inhibition. However, controversial results are noted in these studies. Besides, the static measurement of ankle plantarflexors spasticity may not explain the spasticity in the dynamic status during gait. Furthermore, the effects of NMES on gait symmetry were not established. The purpose of this study was to investigate the effects of NMES applied to ankle dorsiflexors or plantarflexors on ankle control and gait performance in individuals with chronic stroke. Twenty-five stroke subjects with inadequate ankle control were recruited and randomized to the NMES-tibialis anterior (NMES-TA, N=8), NMES-medial gastrocnemius (NMES-MG, N=9) and control group (N=8). Participants in NMES groups received 20 minutes NMES on either tibialis anterior or gastrocnemius followed by 15 minutes of ambulation training 3 times per week for 7 weeks. Participants in control group received 20 minutes of range of motions (ROM) and stretching exercises followed by 15 minutes of ambulation training 3 times per week for 7 weeks. The outcomes included ankle control, muscles strength of dorsiflexors and plantarflexors, spasticity of plantarflexors, EMG activities during walking and gait performance. All assessments were administered at baseline (pre) and after training (post).
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 74502 0
Prof Ray-Yau Wang
Address 74502 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 74502 0
Taiwan, Province Of China
Phone 74502 0
+886228267210
Fax 74502 0
Email 74502 0
rywang@ym.edu.tw
Contact person for public queries
Name 74503 0
Prof Ray-Yau Wang
Address 74503 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University, 112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 74503 0
Taiwan, Province Of China
Phone 74503 0
+886228267210
Fax 74503 0
Email 74503 0
rywang@ym.edu.tw
Contact person for scientific queries
Name 74504 0
Prof Ray-Yau Wang
Address 74504 0
Department of Physical Therapy and Assistive Technology, National Yang-Ming University
112. No. 155, Sec 2, Li Nong St., Shih-Pai, Taipei, Taiwan
Country 74504 0
Taiwan, Province Of China
Phone 74504 0
+886228267210
Fax 74504 0
Email 74504 0
rywang@ym.edu.tw

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