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Trial registered on ANZCTR


Registration number
ACTRN12625000114448
Ethics application status
Approved
Date submitted
23/11/2024
Date registered
31/01/2025
Date last updated
31/01/2025
Date data sharing statement initially provided
31/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of the use of haptic feedback in the recovery of trunk control and gait in post-stroke patients
Scientific title
Efficacy of the use of haptic feedback in the recovery of trunk control and gait in post-stroke patients
Secondary ID [1] 313406 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 335784 0
Gait disorders 335785 0
Trunk control 335787 0
Condition category
Condition code
Neurological 332357 332357 0 0
Other neurological disorders
Physical Medicine / Rehabilitation 332358 332358 0 0
Physiotherapy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The physiotherapy intervention will be conducted using a haptic feedback device (ReMoD V5.0). This device, configured as a vest with electrostimulation and an inclinometer, provides stimuli when the trunk tilts beyond the set degrees, promoting appropriate proprioceptive feedback.
The intervention will include passive and active mobility exercises, postural and motor control, gait recovery, balance, transfers, and lower limb strength, with a task-based approach to facilitate optimal motor pattern acquisition. Examples of key exercises included in the intervention are: reach exercises for weight transfer, squats and strength training with elastic bands, balance circuits, dual-task and motor coordination exercises, and a specific focus on walking (progressively reducing assistance to the correction of compensations, development in different grounds and specific circuits for the improvement of spatiotemporal aspects that need to be worked on). All sessions will be conducted and supervised by a physiotherapist.
The experimental group will use the activated device during treatment sessions in a hospital enviroment. The intervention will consist of six one-hour sessions over 15 days (with 2 days between each session).
Additionally, the experimental group will use the device autonomously for 3 hours daily on all 15 days of the study period. The unsupervised use of the vest will be intended for the basic activities of daily living without any additional instruction to follow any home exercise protocol.
Adherence to the treatment will be monitored through the completion of session attendance checklists and continuous telematic follow-up with the families and patients during the intervention weeks.
Intervention code [1] 329982 0
Treatment: Devices
Comparator / control treatment
Control group. The control group will participate in the same physiotherapy treatment sessions but without the haptic device information as it is a single-blind study where, due to the characteristics of the device's stimulus, a placebo intervention cannot be developed. At unsupervised hours, the control group will also perform their basic activities of daily living, with the sole distinction that they will not receive the proprioceptive feedback provided by the device.
Control group
Active

Outcomes
Primary outcome [1] 339915 0
Trunk impairment
Timepoint [1] 339915 0
Before enrolment, after the two-week treatment period (primary timepoint) and a month after the end of the treatment.
Primary outcome [2] 339920 0
Average Gait Speed
Timepoint [2] 339920 0
Before enrolment, after the two-week treatment period (primary timepoint) and a month after the end of the treatment.
Primary outcome [3] 339921 0
Step Length
Timepoint [3] 339921 0
Before enrolment, after the two-week treatment period (primary timepoint) and a month after the end of the treatment.
Secondary outcome [1] 441905 0
Walking cadence
Timepoint [1] 441905 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [2] 441906 0
Trunk acceleration while walking
Timepoint [2] 441906 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [3] 441907 0
Balance
Timepoint [3] 441907 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [4] 441908 0
Postural control
Timepoint [4] 441908 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [5] 441909 0
Balance and gait function (this will be assessed as a composite outcome).
Timepoint [5] 441909 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [6] 441910 0
Affectation of gait
Timepoint [6] 441910 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [7] 441911 0
Ambulation capacity
Timepoint [7] 441911 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [8] 441912 0
Motor function in Lower Limbs
Timepoint [8] 441912 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [9] 441913 0
Cardiovascular resistance
Timepoint [9] 441913 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [10] 441914 0
Functional capacity independence
Timepoint [10] 441914 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [11] 441915 0
Quality of life
Timepoint [11] 441915 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [12] 441916 0
Anxiety and depression levels (this will be assessed as a composite outcome).
Timepoint [12] 441916 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [13] 441917 0
Pain
Timepoint [13] 441917 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [14] 442096 0
Functionality of gait
Timepoint [14] 442096 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [15] 442097 0
Heart rate variability
Timepoint [15] 442097 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [16] 442098 0
Step time
Timepoint [16] 442098 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [17] 442099 0
HH Base Support
Timepoint [17] 442099 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [18] 442100 0
Swing (% of cycle and time)
Timepoint [18] 442100 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [19] 442101 0
Stance (% of cycle and time)
Timepoint [19] 442101 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [20] 442102 0
Single support (% of cycle and times)
Timepoint [20] 442102 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [21] 443253 0
Trunk Control (this is an additional primary outcome).
Timepoint [21] 443253 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [22] 443254 0
Stride Length (this is an additional primary outcome).
Timepoint [22] 443254 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [23] 443255 0
Lower limbs accelerations while walking
Timepoint [23] 443255 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [24] 443256 0
Blood pressure
Timepoint [24] 443256 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.
Secondary outcome [25] 443257 0
Double support (% of cycle and times)
Timepoint [25] 443257 0
Before enrolment, after the two-week treatment period and a month after the end of the treatment.

Eligibility
Key inclusion criteria
Patients with a first stoke episode.
Patients without contraindications of early mobilitation.
Patients who have signed the informed consent, show voluntariness to participate and can complete the scales and the protocol.
Minimum score of 1 point in Functional Ambulation Category (FAC) or minimum score of 20 points in Postural Assesment Scale for Stroke (PASS).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Intravenous thrombosis or arterial thrombectomy before admission.
Dementia or significant cognitive impairment.
Presence of diseases such as severe cardiovascular disease, arrhythmias or other heart disorders, cancer, epilepsy or infections with risk of septicemia.
Presence of another neurological or musculoskeletal disease (Parkinson's disease, peripheral neuropathy...) or any condition other than the one under study that may influence the development of the patients' gait and balance.
Skin and dermatological alterations.
Pregnancy or possibility of pregnancy.
Pacemaker or other metallic implant.

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)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (www.randomizer.org).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?


The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Statistical Analysis is going to be performed by PASW STATISTIC 18 fr Window.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/02/2025
Actual
Date of last participant enrolment
Anticipated
30/01/2026
Actual
Date of last data collection
Anticipated
2/03/2026
Actual
Sample size
Target
40
Accrual to date
Final
Recruitment outside Australia
Country [1] 26743 0
Spain
State/province [1] 26743 0
Sevilla

Funding & Sponsors
Funding source category [1] 317848 0
University
Name [1] 317848 0
University of Seville
Country [1] 317848 0
Spain
Primary sponsor type
University
Name
Departamento de Fisioterapia, University of Seville
Address
Country
Spain
Secondary sponsor category [1] 320180 0
None
Name [1] 320180 0
Address [1] 320180 0
Country [1] 320180 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316529 0
Comité de Ética de Investigación (CEI de los Hospitales Universitarios Virgen Macarena – Virgen del Rocío de Sevilla)
Ethics committee address [1] 316529 0
Ethics committee country [1] 316529 0
Spain
Date submitted for ethics approval [1] 316529 0
13/02/2024
Approval date [1] 316529 0
10/03/2024
Ethics approval number [1] 316529 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138174 0
Dr Carlos Luque-Moreno
Address 138174 0
Facultad de Enfermería, Fisioterapia y Podología. University of Seville. c/Avenzoar, 6, 41009
Country 138174 0
Spain
Phone 138174 0
+34 954 55 79 06
Fax 138174 0
Email 138174 0
carloslm@us.es
Contact person for public queries
Name 138175 0
Carlos Luque-Moreno
Address 138175 0
Facultad de Enfermería, Fisioterapia y Podología. University of Seville. c/Avenzoar, 6, 41009
Country 138175 0
Spain
Phone 138175 0
+34 954 55 79 06
Fax 138175 0
Email 138175 0
carloslm@us.es
Contact person for scientific queries
Name 138176 0
Anja Hochsprung
Address 138176 0
Hospital Universitario Virgen del Rocío Avda. Manuel Siurot s/n 41013 - Seville
Country 138176 0
Spain
Phone 138176 0
+34 95 671 562 074
Fax 138176 0
Email 138176 0
studyhaptic.contact@gmail.com

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.