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

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ClinicalTrials.gov Identifier: NCT03786341
Recruitment Status : Completed
First Posted : December 25, 2018
Last Update Posted : December 27, 2018
Sponsor:
Information provided by (Responsible Party):
Wan-Yun Huang, Kaohsiung Veterans General Hospital.

Brief 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.

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.


Condition or disease Intervention/treatment Phase
Stroke Device: with auxiliary illuminator Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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: Double (Participant, Outcomes Assessor)
Masking 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.
Primary Purpose: Treatment
Official Title: Kaohsiung Veterans General Hospital , Kaohsiung, Taiwan
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : December 5, 2018
Actual Study Completion Date : December 5, 2018

Arm Intervention/treatment
Experimental: with auxiliary illuminator
the walking training was by conventional strategy with lase quad-cane.
Device: with auxiliary illuminator
Ambulation training with laser quad-cane for 15 minutes and typical physical therapy with strengthening and balance training for 15 minutes.
Other Name: control group

Placebo Comparator: control group
Ambulation training WITHOUT laser quad-cane.
Device: with auxiliary illuminator
Ambulation training with laser quad-cane for 15 minutes and typical physical therapy with strengthening and balance training for 15 minutes.
Other Name: control group




Primary Outcome Measures :
  1. 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 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.

  2. The change of cadence(step/min) 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 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.

  3. The change of duration of stance phase(%) 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 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.

  4. The change of duration of swing phase(%) 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 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.

  5. The change of duration of single support (%) 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 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.

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

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

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


Secondary Outcome Measures :
  1. The Berg balance scale (BBS) [ 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 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.

  2. Barthel index (BI) [ 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. ]
    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.

  3. Timed up and go test (TUG) [ 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. ]
    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.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03786341


Locations
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Taiwan
Kaohsiung Veterans General Hospital ,
Kaohsiung,, Taiwan, 81362
Sponsors and Collaborators
Kaohsiung Veterans General Hospital.
Investigators
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Study Director: Pei-Te Hsu, MD. Kaohsiung Veterans General Hospital.

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Responsible Party: Wan-Yun Huang, Department of Physical Medicine and Rehabilitation, Kaohsiung Veterans General Hospital.
ClinicalTrials.gov Identifier: NCT03786341     History of Changes
Other Study ID Numbers: VGHKS17-CT8-11
First Posted: December 25, 2018    Key Record Dates
Last Update Posted: December 27, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: to publish the journal

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Wan-Yun Huang, Kaohsiung Veterans General Hospital.:
Gait
Stroke
Walking assist device
Auxiliary illuminator
visual feedback

Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases