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StrokeNCT03786341

Efficacy of a Novel Walking Assist Device With Auxiliary Laser Illuminator on Stroke Patients

A study testing with auxiliary illuminator in people with Stroke, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Many patients after acute stage of stroke present with abnormal gait pattern due to weakness or hypertonicity of the affected limbs. Ambulation training with the use of visual feedback strategy is one of the promising rehabilitation in patients with chronic stroke. Read more about this study

Who is it for?
Any age
Conditions the study is for
Stroke
What is being tested?
with auxiliary illuminator
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
30 participants
Where
1 siteTaiwan
Study dates
1 Dec 2017to 5 Dec 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Stroke patients at subacute (stroke symptoms between three months to one year) or chronic stage (stroke symptoms more than 1 year)
  • with hemiplegia
  • with sufficient cognition that could follow the instructions and procedure
  • walk independently for a distance of more than 20 meters with or without the use of a walking aid.

Who cannot join

  • Stroke patients with other neurological diseases like Parkinsonism,
  • Myopathy
  • Multiple sclerosis
  • Spinal cord injury that might interfere with walking ability

Trial locations and contacts

1 site in 1 country.

Taiwan1 site
  • Kaohsiung Veterans General Hospital ,

    Kaohsiung City, 81362

Other trials in Taiwan

About this study

Official title: Kaohsiung Veterans General Hospital , Kaohsiung, Taiwan

Many patients after acute stage of stroke present with abnormal gait pattern due to weakness or hypertonicity of the affected limbs.

Ambulation training with the use of visual feedback strategy is one of the promising rehabilitation in patients with chronic stroke.

Walking assist device with auxiliary laser illuminator during ambulation training could correct gait parameters, improve balance and basic activity of daily living among stroke patients.

Read the detailed description

Facilitation of normal gait is a primary goal of rehabilitation on patients with stroke. The investigators aimed to investigate whether walking assist device with auxiliary lser illuminator (laser quad-cane) providing visual feedback during ambulation could improve parameters of gait cycle and function among patients with chronic stroke.

Methods: This was a randomized-prospective study and participants were recruited to each the experimental and the control group equally. Patients in the experimental group (EG) received 30-minutes rehabilitation, consisting of 15 minutes of walking training with laser quad-cane and 15 minutes of traditional physical therapy (such as strengthening and balance training). Patients in the control group (CG) received the same rehabilitation except that the walking training was by conventional strategy without lase quad-cane. The rehabilitation lasted for 4 weeks, twice per week. Gait parameters were measured by Rehab watch as primary outcomes and Berg's balance scale (BBS), timed-up-and-go test (TUG), and Barthel index were used as secondary outcomes. Both the primary and secondary outcomes were measured before the rehabilitation (baseline), 4 weeks (week 4), and 8 weeks (week 8) after the rehabilitation.

Conditions
Stroke
Being tested
with auxiliary illuminator
Keywords
Gait, Stroke, Walking assist device, Auxiliary illuminator, visual feedback
Medical subject headings
Stroke

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • with auxiliary illuminatorDevice

    Also called control group

    Ambulation training with laser quad-cane for 15 minutes and typical physical therapy with strengthening and balance training for 15 minutes.

Study groups in NCT03786341
Study groupRoleWhat they receive
with auxiliary illuminatorExperimentalthe walking training was by conventional strategy with lase quad-cane.
Receives: Device: with auxiliary illuminator
control groupPlacebo comparatorAmbulation training WITHOUT laser quad-cane.
Receives: Device: with auxiliary illuminator

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The change of stride length (meter) of parameters of gait cycle.

    The primary outcome was the stride length (meter) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

    Measured: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

  2. The change of cadence(step/min) of parameters of gait cycle

    The primary outcome was the cadence(step/min) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

    Measured: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

  3. The change of duration of stance phase(%) of parameters of gait cycle

    The primary outcome was the duration of stance phase(%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

    Measured: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

  4. The change of duration of swing phase(%) of parameters of gait cycle

    The primary outcome was the duration of swing phase(%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

    Measured: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

  5. The change of duration of single support (%) of parameters of gait cycle

    The primary outcome was the duration of single support (%) of parameters of gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

    Measured: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

  6. The change of double support (%)during the gait cycle

    The primary outcome was the double support (%)during the gait cycle. The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

    Measured: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

  7. The change ofangle between toes and the ground at the time of toe-off during a gait cycle (toe-off angle)

    The primary outcome was the angle between toes and the ground at the time of toe-off during a gait cycle (toe-off angle). The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

    Measured: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

  8. The change ofangle between calcaneus and the ground at the time of heel-strike during a gait cycle (heel-strike angle)

    The primary outcome was the angle between calcaneus and the ground at the time of heel-strike during a gait cycle (heel-strike angle). The parameters of gait cycle were measured by a gait analyzer (Reha-Watch1 system; HASOMED1 GmbH, Magdeburg, Germany). Reha-Watch 1 system is based on inertial sensors that allow the quantitative measurement of the important kinematic variables acceleration and angular velocity. The associated software analyzes the sensor signals and calculates temporal (e.g., stride duration, gait phases) and spatial (e.g., stride length, foot angle) parameters on this basis.

    Measured: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

Secondary outcomes (3)
  1. The Berg balance scale (BBS)

    The Berg balance scale (BBS) is a 14 item list with each item consisting of a five-point ordinal scale ranging from 0 to 4, with 0 indicating the lowest level of function and 4 the highest level of function. It is used to objectively determine a patient's ability to safely balance during a series of predetermined tasks. The higher the score means the better ability to maintain the balance. A score of less than 45 indicates individuals may be at greater risk of falling. Studies of various populations and stroke patients have shown high intra-rater and inter-rater reliability (intraclass correlation coefficient [ICC]=0.98 and 0.97, respectively). BBS has been reported that in the elderly population a change of 4 points is needed to be 95% confident that true change has occurred if a patient scores within 45-56 initially, 5 points if they score within 35-44, 7 points if they score within 25-34 and, finally, 5 points if their initial score is within 0-24 on the Berg Balance Scale.

    Measured: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

  2. Barthel index (BI)

    Barthel index (BI) measures the degree of assistance required by an individual on 10 items of mobility and self-care Activity of daily living, including feeding, dressing, grooming, bathing, bowels, bladder, toilet use, transfers, mobility, and stairs. The total scores ranges from 0 to 100. The higher the score means the better of the function. BI has been shown to have portability and has been used in 16 major diagnostic conditions. Studies has demonstrated high inter-rater reliability (0.95) and test-retest reliability (0.89) as well as high correlations (0.74-0.8) with different physical disabilities.

    Measured: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

  3. Timed up and go test (TUG)

    Timed up and go test (TUG) is designed for determining fall risk and measuring the progress of balance, sit to stand, and walking. To perform the test, participant starts in a seated position (50 cm from the floor), stands up upon therapist's command to walk 3 meters, then turn around, walk back to the chair and sit down. The time stops when the patient is seated. If a community dwelling older adults takes 14 seconds or longer, the risk for falling is high. The TUG showed excellent reliability (ICC>0.95) in chronic stroke patients.

    Measured: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Dec 2018
  2. Study start1 Dec 2017
  3. Primary completion5 Dec 2018
  4. Study completion5 Dec 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This was a randomized-prospective study and participants were recruited to each the experimental and the control group equally. Patients in the experimental group (EG) received 30-minutes rehabilitation, consisting of 15 minutes of walking training with laser quad-cane and 15 minutes of traditional physical therapy (such as strengthening and balance training). Patients in the control group (CG) received the same rehabilitation except that the walking training was by conventional strategy without lase quad-cane. The rehabilitation lasted for 4 weeks, twice per week. Gait parameters were measured by Rehab watch as primary outcomes and Berg's balance scale (BBS), timed-up-and-go test (TUG), and Barthel index were used as secondary outcomes. Both the primary and secondary outcomes were measured before the rehabilitation (baseline), 4 weeks (week 4), and 8 weeks (week 8) after the rehabilitation.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03786341
Sponsor's protocol ID
VGHKS17-CT8-11
Status last verified
Oct 2024
First submitted
15 Dec 2018
Last updated
4 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: to publish the journal

Questions about this trial

What is this clinical trial studying?

A study testing with auxiliary illuminator in people with Stroke, run by Kaohsiung Veterans General Hospital. at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The change of stride length (meter) of parameters of gait cycle. (time frame: The study consisted of a screen visit, a baseline visit and follow-up visits at 4 and 8 weeks after the initiation of the study.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.

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