Hemiplegia and/or Hemiparesis Following StrokeNCT04393480
Upper Extremity Robotic Rehabilitation in Patients With Hemiplegia
A study testing Robotic therapy and Conventional therapy in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Sahel Taravati, M.D. at 1 site in Turkey (Türkiye).
Trial summary
Comparison of Upper Extremity Robotic Rehabilitation Efficiency with Conventional Rehabilitation in Patients with Hemiplegia after Cerebrovascular Event Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Hemiplegia and/or Hemiparesis Following Stroke
- What is being tested?
- Robotic therapy and Conventional therapy
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 37 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Apr 2016to 14 Apr 2019
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a single stroke
- Being an adult
- Having a duration of 4 to 30 months after stroke
- A score greater than 16 in mini-mental test
- Upper extremity Brunnstrom stage 2 or higher
- Being a fluent speaker in Turkish.
Who cannot join
- Severe apraxia
- Skin ulcers
- Multiple cerebrovascular events
- Severe decompensated diseases (cardiopulmonary, neurological, orthopedic and psychiatric etc), cardiac pacemakers, severe neuropsychological impairment,
- Neglect syndrome
- Spasticity greater than 3 in Modified Ashworth Scale
- Severe joint contractures
- Botulinum toxin-A injection in their upper extremity and dose change in drugs for spasticity in the last 3 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Upper Extremity Robotic Rehabilitation Efficiency With Conventional Rehabilitation in Patients With Hemiplegia After Cerebrovascular Event
Comparison of Upper Extremity Robotic Rehabilitation Efficiency with Conventional Rehabilitation in Patients with Hemiplegia after Cerebrovascular Event
Read the detailed description
The aim of this single-blind randomized prospective study is to find out whether including robotic therapy in addition to conventional rehabilitation program has an effect on quality of life, motor function and activities of daily living of the hemiplegic patients. Hemiplegic patients diagnosed by anamnesis, physical examination and radiological analysis, which have been referred to the outpatient clinic of Ege University Faculty of Medicine Department of Physical Therapy and Rehabilitation between April 2016 and April 2019 have been taken to the study. The demographic and clinical data of the patients were recorded and they were randomized into 2 groups. 17 patients assigned to the robotic rehabilitation group (Study group) receiving robot-assisted rehabilitation in addition to conventional treatment and 20 assigned to the conventional rehabilitation group (control group) receiving only conventional therapy completed the study. Robotic-based rehabilitation given additionally was arranged to be 30-45 minutes, 5 days per week for 4 weeks. All patients were assessed at the beginning of therapy and at the end of 4th week with Brunnstrom stages of motor recovery, Fugl Meyer Assessment (FMA), hand grip strength, Purdue peg test, Minnesota manual dexterity test, Modified Ashworth Scale (MAS) , Functional Independance Measure (FIM), Stroke Specific Quality of Life Scale (SS-QOL), Nottingham Extended Activities of Daily Living (NEADL) Scale, Montreal Cognitive Assessment (MoCA), Center for Epidemiological Studies Depression Scale (CES- D). In the study, improvements in motor function scores, spasticity, general functioning, activities of daily living, cognitive assessment scale are better in robotic group when compared with control group but this difference was not statistically significant (p>0,05). The investigators have found statistically significant improvement in CES- Depression scale in robotic group compared with control group (p=0,018). Significantly improved motor function gains are observed before and after the treatment in both groups being better in the robotic group however no significant differences were observed between the groups after the treatment. Robotic rehabilitation provides a favorable alternative bringing slight benefits, and also advantageous in terms of work power and psychological recovery so robotic rehabilitation addition to conventional neurological rehabilitation is effective and useful in patient management after stroke or cerebrovascular events.
- Being tested
- Robotic therapy, Conventional therapy
- Keywords
- robotic therapy, rehabilitation, upper extremity, cerebrovascular event, stroke
- Medical subject headings
- Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Robotic therapyOther
ReoGo™ - Motorika robotic therapy - upper extremity robotic rehabilitation system
Conventional therapyOther
Range of Motion (ROM) exercises, muscle strengthening, balance and mobility training, exercises for enhancing activities of daily life, neurophysiological exercises, turnings, bed movements, bridge building, sitting and transfer training, gait training, proprioceptive exercises, balance exercises on the balance board of those affected by the cerebellar system, occupational therapy, cognitive rehabilitation by the relevant psychologist given to those with cognitive impairment
| Study group | Role | What they receive |
|---|---|---|
| Robotic therapy | Active comparator | Robotic rehabilitation and conventional rehabilitation Receives: Other: Robotic therapy; Other: Conventional therapy |
| Conventional therapy | Sham comparator | Conventional rehabilitation Receives: Other: Conventional therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline hand grip strength at 4th week.
Hand grip strength was measured using a hand dynamometer device(Jamar® Hand Dynamometer - Hydraulic - 200 lb Capacity). The measurements were recorded in kilograms. The higher scores indicates better outcome in hand grip strength.
Measured: Up to 4 weeks
Change from baseline hand functions (Minnesota manuel dexterity test) at 4th week.
Manual Dexterity Test is a widely used test which measures the capacity for simple but rapid eye-hand-finger movement. This test includes two parts. The 'placing test' requires the patients to place 58 discs with a diameter of 3.5 cm in the spaces of another set of the same dimensions .The length of the sets requires a wide range of shoulder movements.The 'hand turning test' requires the patient to remove the discs from one set and place them in another, or to reinsert them by removing and turning them. This test was performed for the affected (hemiplegic side) upper limb of the patient (right or left) and the result was recorded in 'seconds'. Short periods show that the result is better.
Measured: Up to 4 weeks
Change from baseline hand functions (Purdue peg board) at 4th week.
The Purdue Pegboard Test is a neuropsychological test of manual dexterity and bimanual coordination. The test involves two different abilities: gross movements of arms, hands, and fingers, and fine motor extremity. This test consists of a board with holes and pins that can be placed on them , also washers and nuts that can be attached to the pins. The patient is asked to insert as many pins as possible into the holes in 30 seconds in a straight row using his right hand.The same is then repeated for the left hand. Finally, by giving 1 minute time, it is passed to the stage where the patient inserts pins, nuts and washers by using two hands.The total score of these 3 stages gives the test score. The higher scores in this test shows better results.
Measured: Up to 4 weeks
Change from baseline spasticity (Modified Ashworth Scale (MAS)) at 4th week.
The Modified Ashworth Scale is the most universally accepted clinical tool used to measure the increase of muscle tone. This scale is a numerical scale that grades spasticity from 0-4, with 0 being no resistance and 4 being a limb rigid in flexion or extension. The greater scores show increased spasticity and worse results.
Measured: Up to 4 weeks
Change from baseline neurophysiological development (Brunnstrom stage) at 4th week.
The Brunnstrom Approach sets out a sequence of stages of recovery from hemiplegia after a stroke, emphasising the synergic pattern of movement which develops during recovery. It consists of six stages assessed separately for the upper limb, hand and lower limb. The higher scores show recovery and better results.
Measured: Up to 4 weeks
Change from baseline motor function (Fugl Meyer Assessment (FMA)) at 4th week.
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The FMA motor assessments for the upper extremity consists of four subsections ( upper extremity, hand wrist, hand, speed/coordination). The total score ranges from 0 to 66, higher scores showing better motor function.
Measured: Up to 4 weeks
Change from baseline general function (Functional Independance Measure (FIM)) at 4th week.
The Functional Independence Measure (FIM) is an 18-item measurement tool that explores an individual's physical, psychological and social function. Tasks that are evaluated using the FIM include six self-care activities, bowel and bladder control, transfers, locomotion, communication and social cognition. It is used to assess and grade the functional status of a person based on the level of assistance he or she requires. Grading categories range from "total assistance with helper"(score 0) to "complete independence with no helper"(score 7). The total score that can be obtained from this scale varies between 18-126, higher scores showing better results.
Measured: Up to 4 weeks
Change from baseline quality of life (Stroke Specific Quality of Life Scale (SS-QOL)) at 4th week.
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke. SS-QOL contains 49 items and 12 fields; mobility, energy, upper limb function, work / production, mental state, self-care, social roles, family roles, vision, language, thinking and personality. Each field consists of at least 3 items, and each item is evaluated on a 5-point Likert scale. Higher scores reflect better function. The total score that can be obtained from SS-QOL varies between 49-245.
Measured: Up to 4 weeks
Change from baseline quality of life (Nottingham Extended Activities of Daily Living (NEADL)) at 4th week.
The Nottingham Extended Activities of Daily Living (NEADL scale) comprises 22 questions to measure the independence in the following areas of daily living: mobility, kitchen, domestic and leisure activities. The total score varies between 0-66. Higher scores show better outcome.
Measured: Up to 4 weeks
Change from baseline cognitive state (MoCA test) at 4th week.
The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for cognitive impairment. Different cognitive functions are evaluated with MoCA. These are attention, memory, concentration, executive functions, language functions, visual structuring skills, abstract thinking, computation and orientation. The score varies between 0 and 30 points and patients who get 21 points and above are considered normal. Higher scores indicate better results.
Measured: Up to 4 weeks
Change from baseline emotional state (CES-depression test) at 4th week.
CES-depression test is a quick self-test, consisting of 20 items that measure depressive feelings and behaviours during the past week and one of the most common screening tests for helping an individual to determine his or her depression quotient.
With the four-dimensional structure of the scale, depressive symptoms, positive effects, somatic symptoms and difficulties in interpersonal relationships were aimed to be measured. Score ranges from 0 to 60, and high scores indicate depression.
Measured: Up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2020
- Study start14 Apr 2016
- Primary completion14 Apr 2019
- Study completion14 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (23)Papers the sponsor has linked to this study.
- Other trials for Hemiplegia and/or Hemiparesis Following StrokeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 37 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahel Taravati, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sahel Taravati, M.D., Ege University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04393480
- Sponsor's protocol ID
- STKC2019
- Status last verified
- May 2020
- First submitted
- 13 May 2020
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Özcan O, Arpacıoğlu O, et al. Nörorehabilitasyon: Güneş & Nobel Tıp Kitabevleri; 2000
Oğuz H, Dursun E, et al. Tıbbi rehabilitasyon: Nobel Tıp Kitabevleri; 2004
Norouzi-Gheidari N, Archambault PS, Fung J. Effects of robot-assisted therapy on stroke rehabilitation in upper limbs: systematic review and meta-analysis of the literature. J Rehabil Res Dev. 2012;49(4):479-96. doi: 10.1682/jrrd.2010.10.0210.
PubMed 22773253Rosati G, Oscari F, Reinkensmeyer DJ, Secoli R, Avanzini F, Spagnol S, Masiero S. Improving robotics for neurorehabilitation: enhancing engagement, performance, and learning with auditory feedback. IEEE Int Conf Rehabil Robot. 2011;2011:5975373. doi: 10.1109/ICORR.2011.5975373.
PubMed 22275577Aisen ML, Krebs HI, Hogan N, McDowell F, Volpe BT. The effect of robot-assisted therapy and rehabilitative training on motor recovery following stroke. Arch Neurol. 1997 Apr;54(4):443-6. doi: 10.1001/archneur.1997.00550160075019.
PubMed 9109746Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.
PubMed 20400552Nef T., Klamroth-Marganska V., Keller U., Riener R. (2016) Three-Dimensional Multi-degree-of-Freedom Arm Therapy Robot (ARMin). In: Reinkensmeyer D., Dietz V. (eds) Neurorehabilitation Technology. Springer, Cham
Chang WH, Kim YH. Robot-assisted Therapy in Stroke Rehabilitation. J Stroke. 2013 Sep;15(3):174-81. doi: 10.5853/jos.2013.15.3.174. Epub 2013 Sep 27.
PubMed 24396811Teasell R, Foley N, Salter K, Bhogal S, Jutai J, Speechley M. Evidence-Based Review of Stroke Rehabilitation: executive summary, 12th edition. Top Stroke Rehabil. 2009 Nov-Dec;16(6):463-88. doi: 10.1310/tsr1606-463. No abstract available.
PubMed 20139049Lum PS, Burgar CG, Shor PC, Majmundar M, Van der Loos M. Robot-assisted movement training compared with conventional therapy techniques for the rehabilitation of upper-limb motor function after stroke. Arch Phys Med Rehabil. 2002 Jul;83(7):952-9. doi: 10.1053/apmr.2001.33101.
PubMed 12098155Teasell R, Bayona N, et al. Background concepts in stroke rehabilitation. Evidence-Based Review of Stroke Rehabilitation. 2008
Masiero S, Armani M, Ferlini G, Rosati G, Rossi A. Randomized trial of a robotic assistive device for the upper extremity during early inpatient stroke rehabilitation. Neurorehabil Neural Repair. 2014 May;28(4):377-86. doi: 10.1177/1545968313513073. Epub 2013 Dec 6.
PubMed 24316679Taveggia G, Borboni A, Salvi L, Mule C, Fogliaresi S, Villafane JH, Casale R. Efficacy of robot-assisted rehabilitation for the functional recovery of the upper limb in post-stroke patients: a randomized controlled study. Eur J Phys Rehabil Med. 2016 Dec;52(6):767-773. Epub 2016 Jul 13.
PubMed 27406879Veerbeek JM, Langbroek-Amersfoort AC, van Wegen EE, Meskers CG, Kwakkel G. Effects of Robot-Assisted Therapy for the Upper Limb After Stroke. Neurorehabil Neural Repair. 2017 Feb;31(2):107-121. doi: 10.1177/1545968316666957. Epub 2016 Sep 24.
PubMed 27597165Prange GB, Jannink MJ, Groothuis-Oudshoorn CG, Hermens HJ, Ijzerman MJ. Systematic review of the effect of robot-aided therapy on recovery of the hemiparetic arm after stroke. J Rehabil Res Dev. 2006 Mar-Apr;43(2):171-84. doi: 10.1682/jrrd.2005.04.0076.
PubMed 16847784
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Upper Extremity Robotic Rehabilitation Efficiency With Conventional Rehabilitation in Patients With Hemiplegia After Cerebrovascular Event
- ClinicalTrials.gov ID
- NCT04393480
- Acronym / sponsor ID
- STKC2019
- Keywords
- robotic therapy, rehabilitation, upper extremity, cerebrovascular event, stroke
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 37 participants (actual)
- Lead sponsor
- Sahel Taravati, M.D.University, hospital or other
- Study start
- 14 Apr 2016 (actual)
- Primary completion
- 14 Apr 2019 (actual)
- Study completion
- 14 Apr 2019 (actual)
- First posted
- 19 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Comparison of Upper Extremity Robotic Rehabilitation Efficiency with Conventional Rehabilitation in Patients with Hemiplegia after Cerebrovascular Event
Detailed description
The aim of this single-blind randomized prospective study is to find out whether including robotic therapy in addition to conventional rehabilitation program has an effect on quality of life, motor function and activities of daily living of the hemiplegic patients. Hemiplegic patients diagnosed by anamnesis, physical examination and radiological analysis, which have been referred to the outpatient clinic of Ege University Faculty of Medicine Department of Physical Therapy and Rehabilitation between April 2016 and April 2019 have been taken to the study. The demographic and clinical data of the patients were recorded and they were randomized into 2 groups. 17 patients assigned to the robotic rehabilitation group (Study group) receiving robot-assisted rehabilitation in addition to conventional treatment and 20 assigned to the conventional rehabilitation group (control group) receiving only conventional therapy completed the study. Robotic-based rehabilitation given additionally was arranged to be 30-45 minutes, 5 days per week for 4 weeks. All patients were assessed at the beginning of therapy and at the end of 4th week with Brunnstrom stages of motor recovery, Fugl Meyer Assessment (FMA), hand grip strength, Purdue peg test, Minnesota manual dexterity test, Modified Ashworth Scale (MAS) , Functional Independance Measure (FIM), Stroke Specific Quality of Life Scale (SS-QOL), Nottingham Extended Activities of Daily Living (NEADL) Scale, Montreal Cognitive Assessment (MoCA), Center for Epidemiological Studies Depression Scale (CES- D). In the study, improvements in motor function scores, spasticity, general functioning, activities of daily living, cognitive assessment scale are better in robotic group when compared with control group but this difference was not statistically significant (p>0,05). The investigators have found statistically significant improvement in CES- Depression scale in robotic group compared with control group (p=0,018). Significantly improved motor function gains are observed before and after the treatment in both groups being better in the robotic group however no significant differences were observed between the groups after the treatment. Robotic rehabilitation provides a favorable alternative bringing slight benefits, and also advantageous in terms of work power and psychological recovery so robotic rehabilitation addition to conventional neurological rehabilitation is effective and useful in patient management after stroke or cerebrovascular events.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Robotic therapy | Active comparator | Other: Robotic therapy, Other: Conventional therapyRobotic rehabilitation and conventional rehabilitation |
| Conventional therapy | Sham comparator | Other: Conventional therapyConventional rehabilitation |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Having a single stroke
- Being an adult
- Having a duration of 4 to 30 months after stroke
- A score greater than 16 in mini-mental test
- Upper extremity Brunnstrom stage 2 or higher
Key exclusion criteria (8 listed)
- Severe apraxia
- Skin ulcers
- Multiple cerebrovascular events
- Severe decompensated diseases (cardiopulmonary, neurological, orthopedic and psychiatric etc), cardiac pacemakers, severe neuropsychological impairment,
- Neglect syndrome
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Robotic therapyReoGo™ - Motorika robotic therapy - upper extremity robotic rehabilitation system | Other | Robotic therapy |
| Conventional therapyRange of Motion (ROM) exercises, muscle strengthening, balance and mobility training, exercises for enhancing activities of daily life, neurophysiological exercises, turnings, bed movements, bridge building, sitting and transfer training, gait training, proprioceptive exercises, balance exercises on the balance board of those affected by the cerebellar system, occupational therapy, cognitive rehabilitation by the relevant psychologist given to those with cognitive impairment | Other | Conventional therapy, Robotic therapy |
Primary outcome
Change from baseline hand grip strength at 4th week.
Time frame: Up to 4 weeks
Hand grip strength was measured using a hand dynamometer device(Jamar® Hand Dynamometer - Hydraulic - 200 lb Capacity). The measurements were recorded in kilograms. The higher scores indicates better outcome in hand grip strength.
Change from baseline hand functions (Minnesota manuel dexterity test) at 4th week.
Time frame: Up to 4 weeks
Manual Dexterity Test is a widely used test which measures the capacity for simple but rapid eye-hand-finger movement. This test includes two parts. The 'placing test' requires the patients to place 58 discs with a diameter of 3.5 cm in the spaces of another set of the same dimensions .The length of the sets requires a wide range of shoulder movements.The 'hand turning test' requires the patient to remove the discs from one set and place them in another, or to reinsert them by removing and turning them. This test was performed for the affected (hemiplegic side) upper limb of the patient (right or left) and the result was recorded in 'seconds'. Short periods show that the result is better.
Change from baseline hand functions (Purdue peg board) at 4th week.
Time frame: Up to 4 weeks
The Purdue Pegboard Test is a neuropsychological test of manual dexterity and bimanual coordination. The test involves two different abilities: gross movements of arms, hands, and fingers, and fine motor extremity. This test consists of a board with holes and pins that can be placed on them , also washers and nuts that can be attached to the pins. The patient is asked to insert as many pins as possible into the holes in 30 seconds in a straight row using his right hand.The same is then repeated for the left hand. Finally, by giving 1 minute time, it is passed to the stage where the patient inserts pins, nuts and washers by using two hands.The total score of these 3 stages gives the test score. The higher scores in this test shows better results.
Change from baseline spasticity (Modified Ashworth Scale (MAS)) at 4th week.
Time frame: Up to 4 weeks
The Modified Ashworth Scale is the most universally accepted clinical tool used to measure the increase of muscle tone. This scale is a numerical scale that grades spasticity from 0-4, with 0 being no resistance and 4 being a limb rigid in flexion or extension. The greater scores show increased spasticity and worse results.
Change from baseline neurophysiological development (Brunnstrom stage) at 4th week.
Time frame: Up to 4 weeks
The Brunnstrom Approach sets out a sequence of stages of recovery from hemiplegia after a stroke, emphasising the synergic pattern of movement which develops during recovery. It consists of six stages assessed separately for the upper limb, hand and lower limb. The higher scores show recovery and better results.
Change from baseline motor function (Fugl Meyer Assessment (FMA)) at 4th week.
Time frame: Up to 4 weeks
Fugl-Meyer Assessment (FMA) scale is an index to assess the sensorimotor impairment in individuals who have had stroke. The FMA motor assessments for the upper extremity consists of four subsections ( upper extremity, hand wrist, hand, speed/coordination). The total score ranges from 0 to 66, higher scores showing better motor function.
Change from baseline general function (Functional Independance Measure (FIM)) at 4th week.
Time frame: Up to 4 weeks
The Functional Independence Measure (FIM) is an 18-item measurement tool that explores an individual's physical, psychological and social function. Tasks that are evaluated using the FIM include six self-care activities, bowel and bladder control, transfers, locomotion, communication and social cognition. It is used to assess and grade the functional status of a person based on the level of assistance he or she requires. Grading categories range from "total assistance with helper"(score 0) to "complete independence with no helper"(score 7). The total score that can be obtained from this scale varies between 18-126, higher scores showing better results.
Change from baseline quality of life (Stroke Specific Quality of Life Scale (SS-QOL)) at 4th week.
Time frame: Up to 4 weeks
The Stroke Specific Quality Of Life scale (SS-QOL) is a patient-centered outcome measure intended to provide an assessment of health-related quality of life (HRQOL) specific to patients with stroke. SS-QOL contains 49 items and 12 fields; mobility, energy, upper limb function, work / production, mental state, self-care, social roles, family roles, vision, language, thinking and personality. Each field consists of at least 3 items, and each item is evaluated on a 5-point Likert scale. Higher scores reflect better function. The total score that can be obtained from SS-QOL varies between 49-245.
Change from baseline quality of life (Nottingham Extended Activities of Daily Living (NEADL)) at 4th week.
Time frame: Up to 4 weeks
The Nottingham Extended Activities of Daily Living (NEADL scale) comprises 22 questions to measure the independence in the following areas of daily living: mobility, kitchen, domestic and leisure activities. The total score varies between 0-66. Higher scores show better outcome.
Change from baseline cognitive state (MoCA test) at 4th week.
Time frame: Up to 4 weeks
The Montreal Cognitive Assessment (MoCA) is a brief 30-question test that takes around 10 to 12 minutes to complete and helps assess people for cognitive impairment. Different cognitive functions are evaluated with MoCA. These are attention, memory, concentration, executive functions, language functions, visual structuring skills, abstract thinking, computation and orientation. The score varies between 0 and 30 points and patients who get 21 points and above are considered normal. Higher scores indicate better results.
Change from baseline emotional state (CES-depression test) at 4th week.
Time frame: Up to 4 weeks
CES-depression test is a quick self-test, consisting of 20 items that measure depressive feelings and behaviours during the past week and one of the most common screening tests for helping an individual to determine his or her depression quotient. With the four-dimensional structure of the scale, depressive symptoms, positive effects, somatic symptoms and difficulties in interpersonal relationships were aimed to be measured. Score ranges from 0 to 60, and high scores indicate depression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2020.
- BackgroundÖzcan O, Arpacıoğlu O, et al. Nörorehabilitasyon: Güneş & Nobel Tıp Kitabevleri; 2000
- BackgroundOğuz H, Dursun E, et al. Tıbbi rehabilitasyon: Nobel Tıp Kitabevleri; 2004
- Background: PubMed 22773253Norouzi-Gheidari N, Archambault PS, Fung J. Effects of robot-assisted therapy on stroke rehabilitation in upper limbs: systematic review and meta-analysis of the literature. J Rehabil Res Dev. 2012;49(4):479-96. doi: 10.1682/jrrd.2010.10.0210.
- Background: PubMed 22275577Rosati G, Oscari F, Reinkensmeyer DJ, Secoli R, Avanzini F, Spagnol S, Masiero S. Improving robotics for neurorehabilitation: enhancing engagement, performance, and learning with auditory feedback. IEEE Int Conf Rehabil Robot. 2011;2011:5975373. doi: 10.1109/ICORR.2011.5975373.
- Background: PubMed 9109746Aisen ML, Krebs HI, Hogan N, McDowell F, Volpe BT. The effect of robot-assisted therapy and rehabilitative training on motor recovery following stroke. Arch Neurol. 1997 Apr;54(4):443-6. doi: 10.1001/archneur.1997.00550160075019.
- Background: PubMed 20400552Lo AC, Guarino PD, Richards LG, Haselkorn JK, Wittenberg GF, Federman DG, Ringer RJ, Wagner TH, Krebs HI, Volpe BT, Bever CT Jr, Bravata DM, Duncan PW, Corn BH, Maffucci AD, Nadeau SE, Conroy SS, Powell JM, Huang GD, Peduzzi P. Robot-assisted therapy for long-term upper-limb impairment after stroke. N Engl J Med. 2010 May 13;362(19):1772-83. doi: 10.1056/NEJMoa0911341. Epub 2010 Apr 16.
- BackgroundNef T., Klamroth-Marganska V., Keller U., Riener R. (2016) Three-Dimensional Multi-degree-of-Freedom Arm Therapy Robot (ARMin). In: Reinkensmeyer D., Dietz V. (eds) Neurorehabilitation Technology. Springer, Cham
- Background: PubMed 24396811Chang WH, Kim YH. Robot-assisted Therapy in Stroke Rehabilitation. J Stroke. 2013 Sep;15(3):174-81. doi: 10.5853/jos.2013.15.3.174. Epub 2013 Sep 27.
- Background: PubMed 20139049Teasell R, Foley N, Salter K, Bhogal S, Jutai J, Speechley M. Evidence-Based Review of Stroke Rehabilitation: executive summary, 12th edition. Top Stroke Rehabil. 2009 Nov-Dec;16(6):463-88. doi: 10.1310/tsr1606-463. No abstract available.
- Background: PubMed 12098155Lum PS, Burgar CG, Shor PC, Majmundar M, Van der Loos M. Robot-assisted movement training compared with conventional therapy techniques for the rehabilitation of upper-limb motor function after stroke. Arch Phys Med Rehabil. 2002 Jul;83(7):952-9. doi: 10.1053/apmr.2001.33101.
- BackgroundTeasell R, Bayona N, et al. Background concepts in stroke rehabilitation. Evidence-Based Review of Stroke Rehabilitation. 2008
- Background: PubMed 24316679Masiero S, Armani M, Ferlini G, Rosati G, Rossi A. Randomized trial of a robotic assistive device for the upper extremity during early inpatient stroke rehabilitation. Neurorehabil Neural Repair. 2014 May;28(4):377-86. doi: 10.1177/1545968313513073. Epub 2013 Dec 6.
- Individual participant dataSharing planned: No
Related trials for Hemiplegia and/or Hemiparesis Following Stroke
Recruiting
High-Intensity Laser Therapy in Hemiplegic Shoulder Pain
Hemiplegia and/or Hemiparesis Following Stroke
Active, not recruiting
The Effect of Good Limb Position Management Assistive Devices on Preventing Shoulder Subluxation in Hemiplegic Patients
Hemiplegia and/or Hemiparesis Following Stroke
Not yet recruiting
Immediate Effects of PETTLEP-Based AOMI on Upper Limb Kinematics in Stroke Survivors
Stroke, Hemiplegia
Recruiting
Effect of Transcutaneous Electrical Nerve Stimulation on Post-stroke Patients
Hemiplegia and/or Hemiparesis Following Stroke, Anterior Circulation Stroke of Uncertain Pathology
RecruitingPhase 1
Psychedelic Healing: Adjunct Therapy Harnessing Opened Malleability
Stroke, Chronic Stroke
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Robotic therapy and Conventional therapy in people with Hemiplegia and/or Hemiparesis Following Stroke, run by Sahel Taravati, M.D. at 1 site in Turkey (Türkiye).
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 6 inclusion and 8 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 19 May 2020. 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 Turkey (Türkiye). 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?
Change from baseline hand grip strength at 4th week. (time frame: Up to 4 weeks). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04393480, which also lists 23 linked publications.
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 19 May 2020.