An interventional study of Orthosis in Stroke, Cerebrovascular Disorders and Brain Diseases, sponsored by Sunnaas Rehabilitation Hospital. Status unknown at 1 site in Norway. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-04-16.
Sponsored by Sunnaas Rehabilitation Hospital · Not applicable, Interventional, and Treatment
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.
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:
219 studies on the registry are indexed under Cerebral Infarction; 46 are open to participants now.
This study's planned enrollment of 60 is below the median of 120 across 139 interventional studies indexed under Cerebral Infarction.
Browse Cerebral Infarction studies →Sunnaas Rehabilitation Hospital is the lead sponsor of 24 studies on the registry; 1 is open to participants now.
Compared within Cerebral Infarction, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Stroke. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Orthosis
The group will receive the same amount of a study-specific training program without the orthotic device.
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.
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.
Time frame: Participants will be tested at baseline, week 3 and week 12.
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).
Time frame: 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.
Time frame: Participants will be tested at baseline, week 3 and week 12.
Nine-peg-hole test
Measure to assess fine manual dexterity
Time frame: Participants will be tested at baseline, week 3 and week 12.
Grip-strength / Dynamometer
Measure to assess isometric strength of the hand.
Time frame: 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.
Time frame: 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.
Time frame: 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.
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
A semi-structured interview with questions on the satisfaction and subjective perception of the exercise program and orthotic device.
Time frame: 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.
Time frame: 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.
Time frame: Participants will be tested at baseline, week 3 and week 12.
Plan to share: No
No publications or documents are linked to this record.
Ran from Jan 2018 to primary completion in Dec 2019, 23 months.
Of 27 interventional studies with no phase under Cerebral Infarction, half reached primary completion within 28 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 49. This study's 23 months is below that.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.
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Sunnaas Rehabilitation Hospital