StrokeTECHITONCT03396939
The Technology-assisted, High Intensive, Task-oriented Exercise Trial
A study testing Orthosis in people with Stroke and Cerebrovascular Disorders, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
Trial summary
The interventional study aims to increase the knowledge on arm and hand rehabilitation after stroke within community-based services. The primary objective of the study is to evaluate the feasibility and clinical usefulness of the arm and hand training program (focusing on functional goal- and task-oriented daily life… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stroke, Cerebrovascular Disorders, Brain Diseases
- What is being tested?
- Orthosis
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteNorway
- Study dates
- 10 Jan 2018to Jun 2020
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosis of ischemic or hemorrhagic stroke by World Health Organization criteria;
- able to consent;
- age ≥ 18 years;
- upper extremity hemiparesis with Motor Assessment Scale (MAS) ≤ 3 for hand function;
- able to comply with the requirements of the protocol
Who cannot join
- traumatic or nonvascular brain injury;
- subarachnoid or primary intraventricular haemorrhage;
- orthopedic / malfunctions in the arm and hand not related to stroke;
- severe co-morbidity;
- cognitive disorders with a Montreal Cognitive Assessment (MoCA) ≤ 20.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Technology-assisted, High Intensive, Task-oriented Exercise Program to Improve Arm and Hand Functions in Persons With Stroke. The TECHITO Feasibility and Pilot Trial.
The interventional study aims to increase the knowledge on arm and hand rehabilitation after stroke within community-based services. The primary objective of the study is to evaluate the feasibility and clinical usefulness of the arm and hand training program (focusing on functional goal- and task-oriented daily life exercises) in combination with the use of an orthotic device in terms of patient compliance and improvement of outcomes. The secondary objective is to compare the effectiveness of the program with or without the use of an orthotic device in a randomized controlled trial.
Read the detailed description
Two third of all persons with stroke have a reduced arm and hand function in the acute stage. Three months after the debut of stroke event, 50% of these patients will still have a remaining disability with chronic problems of hand function (Kwakkel et al., 2003; Lawrence et al., 2001). The consequences are grave for these individuals, considering arm and hand function to be important for independent living and related quality of life. In this context, an intervention, combining functional goal- and task- oriented exercises with a supportive orthotic device in the community-based rehabilitation unit and home environment, is hypothesized to increase perceived goal achievement, repetition, as well as the intensity of exercises. An initial feasibility study followed by a pilot randomized controlled trial could strengthen the evidence for the arm and hand interventions after stroke, and support the generalizability of the results to a larger sample.
The exercise program is outlined in accordance with the Frequency, Intensity, Type and Time (FITT) principles of training. The proposed training adopts a task-oriented approach as practised today in the participating facilities. The program is standardized in close collaboration with physio- and occupational therapists on the basis of contemporary motor learning and exercise theories. An orthosis supporting the wrist will be used as supporting device, hypothetically enhancing the performance of the exercise groups.
The intervention will be performed individually and will run for 12 weeks both at the community rehabilitation unit (3 times week for 3 weeks) and at home (9 weeks).
Time: one session at the community rehabilitation unit is approximately 60 minutes with a focus on trunk, arm and hand training. Exercises at home will be carried out in minimum 2 hours per day.
Frequency: 5 days per week at home-exercises with/ without the orthotic device.
Intensity: moderate to maximal in view of strength, muscle endurance and concentration, as evaluated individually by use of Borg scale.
Type:
- fine motor coordination exercises such as pinch grip, writing, handling objects and stretching of fingers, hand, and wrist;
- various combined activities such as turning pages, distributing cards, washing up, folding laundry, sweeping floor;
- strengthening exercises such as gross motor exercises for trunk, arm, hand and fingers with and without weights.
- Conditions
- Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Vascular Diseases, Nervous System Diseases
- Being tested
- Orthosis
- Keywords
- Stroke, Rehabilitation, Task oriented training, Motor recovery, Hand function, Arm function
- Medical subject headings
- Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Vascular Diseases, Nervous System Diseases, Cerebral Infarction, Brain Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OrthosisDevice
All participants in the experimental group will be given an orthotic device for a 12-week period to use alongside their functional goal- and task-oriented training program.
| Study group | Role | What they receive |
|---|---|---|
| Orthosis | Experimental | The intervention will be performed individually and will run for 12 weeks both at the community rehabilitation unit (3 times a week for 3 weeks) and at home (9 weeks). The group will receive an orthotic device for use during the study-specific exercises. Receives: Device: Orthosis |
| Control | No intervention | The group will receive the same amount of a study-specific training program without the orthotic device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Action Research Arm Test (ARAT) scores
The ARAT is a 19 items arm- and hand-specific measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale. The total score on the ARAT ranges from 0 to 57, with the higher scores indicating better performance. A minimal clinical change of 10% on total score of ARAT will be considered as clinically relevant.
Measured: Participants will be tested at baseline, week 3 and week 12.
Secondary outcomes (10)
Fugl- Meyer Assessment- Upper Extremity
Measure to assess reflex activity, movement control and muscle strength in the upper extremity. Scale items are scored on the basis of ability to complete the item using a 3-point ordinal scale where 0=cannot perform, 1=performs partially and 2=performs fully. Motor score for upper extremity: ranges from 0 to 66 points (normal motor performance).
Measured: Participants will be tested at baseline, week 3 and week 12.
Motor Assessment Scale items 3, 6, 7, and 8
Measure to assess performance of functional tasks. The items are assessed using a 7-point scale from 0 - 6, with a score of 6 indicates optimal motor behavior.
Measured: Participants will be tested at baseline, week 3 and week 12.
Nine-peg-hole test
Measure to assess fine manual dexterity
Measured: Participants will be tested at baseline, week 3 and week 12.
Grip-strength / Dynamometer
Measure to assess isometric strength of the hand.
Measured: Participants will be tested at baseline, week 3 and week 12.
EQ-5D Instrument
Measure to assess health-related quality of life. The instrument comprises 5 dimensions (mobility, self care, usual activities, pain/discomfort, anxiety/depression). Each dimension has 5 levels.
Measured: Participants will be tested at baseline, week 3 and week 12.
Modified Ashworth Scale
Measure to assess resistance during passive soft-tissue stretching and spasticity. Scores range from 0-4 with 0- no increase in muscle tone to 4- affected part(s) rigid in flexion or extension.
Measured: Participants will be tested at baseline, week 3 and week 12.
Borg scale
Measure to gauge individual level of intensity in training. The scale ranges from 6 to 20, where 6 means "no exertion at all" and 20 means "maximal exertion. Moderate training register 11 to 14 on the Borg scale, while vigorous exercises usually rate a 15 or higher.
Measured: Participants will be tested after each training session at the institution, and upon completion of the intervention.
Subjective evaluation of the exercise program and the use of orthotic device
A semi-structured interview with questions on the satisfaction and subjective perception of the exercise program and orthotic device.
Measured: Participants will be interviewed at week 3 and week 12.
Registration data
Demographic data will be registered. Descriptive data will be recorded in regard of the patients' age, gender, occupation, civil and residential status, stroke incidence, treatment, medication and length of stay in the institution.
Measured: Baseline
functional near infrared spectroscopy (fNIRS)
In this study, 44 channel near-infrared brain functional imaging system (ETG-4100, Hitachi Medical Co., Tokyo, Japan) will be used for measurement. The concentration changes of oxyhemoglobin (Oxy -Hb) and deoxyhemoglobin (Deoxy-Hb) in the cerebral cortex are measured continuously. We focus on several Regions of interest (ROI): bilateral sensorimotor cortex (SMC), premotor cortex (PMC) , supplementary motor area (SMA). We aim a) to confirm significant activation channel in task state, b) to compare the intragroup/intergroup concentration changes of oxyhemoglobin and deoxyhemoglobin before and after the intervention, and c) to analyze hemodynamics corresponding curve of ROI including difference of amplitude and latent period when oxyhemoglobin reaches the peak.
Measured: Participants will be tested at baseline, week 3 and week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2018
- Study start10 Jan 2018
- Primary completion20 Dec 2019
- Study completionJun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is a two-step trial: first with the feasibility trial in a cohort of stroke patients regardless of location and temporal evolution then followed by a pilot randomized controlled study (RCT). The feasibility study will include 30 stroke patients with reduced arm and hand functions to explore and establish a target group for whom the intervention may be best suitable in terms of compliance and improvement of perceived use. The pilot RCT will include 30 first-time stroke patients with reduced arm and hand functions. The experimental group (15 patients) will receive an orthotic device for use during the exercises, while the control group (15 patients) will not. Both groups will receive the same amount of a study-specific training program.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnaas Rehabilitation Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Unicare Fram, SunHF Aker Polklinikk
- Responsible party
- Principal investigator, Yih Wong, Sunnaas Rehabilitation Hospital
- Investigators
- Johan K Stanghelle, MD, PhD, Study director, Sunnaas Rehabilitation Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03396939
- Sponsor's protocol ID
- 2017/1915 D
- Acronym
- TECHITO
- Status last verified
- Apr 2020
- First submitted
- 2 Jan 2018
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wong Y, Ada L, Manum G, Langhammer B. Upper limb practice with a dynamic hand orthosis to improve arm and hand function in people after stroke: a feasibility study. Pilot Feasibility Stud. 2023 Jul 27;9(1):132. doi: 10.1186/s40814-023-01353-8.
PubMed 37501217
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technology-assisted, High Intensive, Task-oriented Exercise Program to Improve Arm and Hand Functions in Persons With Stroke. The TECHITO Feasibility and Pilot Trial.
- ClinicalTrials.gov ID
- NCT03396939
- Acronym / sponsor ID
- TECHITO / 2017/1915 D
- Conditions
- Stroke, Cerebrovascular Disorders, Brain Diseases, Central Nervous System Diseases, Vascular Diseases, Nervous System Diseases
- Keywords
- Stroke, Rehabilitation, Task oriented training, Motor recovery, Hand function, Arm function
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sunnaas Rehabilitation HospitalUniversity, hospital or other
- Collaborators
- Unicare Fram, SunHF Aker Polklinikk
- Study start
- 10 Jan 2018 (actual)
- Primary completion
- 20 Dec 2019 (actual)
- Study completion
- Jun 2020 (estimated)
- First posted
- 11 Jan 2018 (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.
The interventional study aims to increase the knowledge on arm and hand rehabilitation after stroke within community-based services. The primary objective of the study is to evaluate the feasibility and clinical usefulness of the arm and hand training program (focusing on functional goal- and task-oriented daily life exercises) in combination with the use of an orthotic device in terms of patient compliance and improvement of outcomes. The secondary objective is to compare the effectiveness of the program with or without the use of an orthotic device in a randomized controlled trial.
Detailed description
Two third of all persons with stroke have a reduced arm and hand function in the acute stage. Three months after the debut of stroke event, 50% of these patients will still have a remaining disability with chronic problems of hand function (Kwakkel et al., 2003; Lawrence et al., 2001). The consequences are grave for these individuals, considering arm and hand function to be important for independent living and related quality of life. In this context, an intervention, combining functional goal- and task- oriented exercises with a supportive orthotic device in the community-based rehabilitation unit and home environment, is hypothesized to increase perceived goal achievement, repetition, as well as the intensity of exercises. An initial feasibility study followed by a pilot randomized controlled trial could strengthen the evidence for the arm and hand interventions after stroke, and support the generalizability of the results to a larger sample.
The exercise program is outlined in accordance with the Frequency, Intensity, Type and Time (FITT) principles of training. The proposed training adopts a task-oriented approach as practised today in the participating facilities. The program is standardized in close collaboration with physio- and occupational therapists on the basis of contemporary motor learning and exercise theories. An orthosis supporting the wrist will be used as supporting device, hypothetically enhancing the performance of the exercise groups.
The intervention will be performed individually and will run for 12 weeks both at the community rehabilitation unit (3 times week for 3 weeks) and at home (9 weeks).
Time: one session at the community rehabilitation unit is approximately 60 minutes with a focus on trunk, arm and hand training. Exercises at home will be carried out in minimum 2 hours per day.
Frequency: 5 days per week at home-exercises with/ without the orthotic device.
Intensity: moderate to maximal in view of strength, muscle endurance and concentration, as evaluated individually by use of Borg scale.
Type:
- fine motor coordination exercises such as pinch grip, writing, handling objects and stretching of fingers, hand, and wrist;
- various combined activities such as turning pages, distributing cards, washing up, folding laundry, sweeping floor;
- strengthening exercises such as gross motor exercises for trunk, arm, hand and fingers with and without weights.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a two-step trial: first with the feasibility trial in a cohort of stroke patients regardless of location and temporal evolution then followed by a pilot randomized controlled study (RCT). The feasibility study will include 30 stroke patients with reduced arm and hand functions to explore and establish a target group for whom the intervention may be best suitable in terms of compliance and improvement of perceived use. The pilot RCT will include 30 first-time stroke patients with reduced arm and hand functions. The experimental group (15 patients) will receive an orthotic device for use during the exercises, while the control group (15 patients) will not. Both groups will receive the same amount of a study-specific training program.
| Arm | Type | Receives |
|---|---|---|
| Orthosis | Experimental | Device: OrthosisThe intervention will be performed individually and will run for 12 weeks both at the community rehabilitation unit (3 times a week for 3 weeks) and at home (9 weeks). The group will receive an orthotic device for use during the study-specific exercises. |
| Control | No intervention | –The group will receive the same amount of a study-specific training program without the orthotic device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- diagnosis of ischemic or hemorrhagic stroke by World Health Organization criteria;
- able to consent;
- age ≥ 18 years;
- upper extremity hemiparesis with Motor Assessment Scale (MAS) ≤ 3 for hand function;
- able to comply with the requirements of the protocol
Key exclusion criteria (5 listed)
- traumatic or nonvascular brain injury;
- subarachnoid or primary intraventricular haemorrhage;
- orthopedic / malfunctions in the arm and hand not related to stroke;
- severe co-morbidity;
- cognitive disorders with a Montreal Cognitive Assessment (MoCA) ≤ 20.
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 |
|---|---|---|
| OrthosisAll participants in the experimental group will be given an orthotic device for a 12-week period to use alongside their functional goal- and task-oriented training program. | Device | Orthosis |
Primary outcome
Change in Action Research Arm Test (ARAT) scores
Time frame: Participants will be tested at baseline, week 3 and week 12.
The ARAT is a 19 items arm- and hand-specific measure divided into 4 sub-tests (grasp, grip, pinch, and gross arm movement). Performance on each item is rated on a 4-point ordinal scale. The total score on the ARAT ranges from 0 to 57, with the higher scores indicating better performance. A minimal clinical change of 10% on total score of ARAT will be considered as clinically relevant.
10 secondary outcomes
Fugl- Meyer Assessment- Upper Extremity
Time frame: Participants will be tested at baseline, week 3 and week 12.
Motor Assessment Scale items 3, 6, 7, and 8
Time frame: Participants will be tested at baseline, week 3 and week 12.
Nine-peg-hole test
Time frame: Participants will be tested at baseline, week 3 and week 12.
Grip-strength / Dynamometer
Time frame: Participants will be tested at baseline, week 3 and week 12.
EQ-5D Instrument
Time frame: Participants will be tested at baseline, week 3 and week 12.
Modified Ashworth Scale
Time frame: Participants will be tested at baseline, week 3 and week 12.
Borg scale
Time frame: Participants will be tested after each training session at the institution, and upon completion of the intervention.
Subjective evaluation of the exercise program and the use of orthotic device
Time frame: Participants will be interviewed at week 3 and week 12.
Registration data
Time frame: Baseline
functional near infrared spectroscopy (fNIRS)
Time frame: Participants will be tested at baseline, week 3 and week 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2020.
- Derived from this study: PubMed 37501217Wong Y, Ada L, Manum G, Langhammer B. Upper limb practice with a dynamic hand orthosis to improve arm and hand function in people after stroke: a feasibility study. Pilot Feasibility Stud. 2023 Jul 27;9(1):132. doi: 10.1186/s40814-023-01353-8.
- Individual participant dataSharing planned: No
Related trials for Stroke
Recruiting
Delay AvoIding Primary Evaluation for ThRombectomy of Acute StrokE Patients With Large Vessel OCclusion in the Angiography SuiTe
Stroke, Acute
RecruitingPhase 4
Xeomin® and Gait Related Mobility After Stroke
Stroke
RecruitingObservational study
Implementing Transcranial Direct Current Stimulation in a Rehabilitation Setting
Aphasia, Stroke
Not yet recruiting
EEG Feedback-Based Vagus Nerve Stimulation for Post-Stroke Dysphagia
Ischemic Stroke, Post-stroke Dysphagia
RecruitingObservational study
Development and Validation of Risk Prediction Models for Stroke and Cognitive Impairment in Moyamoya Disease and Moyamoya Syndrome
Moyamoya Disease, Moyamoya Syndrome
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.
Johan K Stanghelle, MD, PhD study director
Sunnaas Rehabilitation Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Orthosis in people with Stroke and Cerebrovascular Disorders, run by Sunnaas Rehabilitation Hospital at 1 site in Norway.
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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 16 Apr 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 Norway. 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. 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?
Results are not available in the source record.
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 in Action Research Arm Test (ARAT) scores (time frame: Participants will be tested at baseline, week 3 and week 12.). 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 NCT03396939, which also lists 1 linked publication.
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 16 Apr 2020.