Clinical trial NCT03396939: The Technology-assisted, High Intensive, Task-oriented Exercise Trial
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.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Vascular Diseases
Nervous System Diseases
Cerebral Infarction
Brain Ischemia
Keywords: Stroke
Rehabilitation
Task oriented training
Motor recovery
Hand function
Arm function
Lead sponsor: Sunnaas Rehabilitation Hospital
Sponsor class: OTHER
Collaborators: name: Unicare Fram
name: SunHF Aker Polklinikk
First posted: 2018-01-11
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

Brief 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 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:

1. fine motor coordination exercises such as pinch grip, writing, handling objects and stretching of fingers, hand, and wrist;
2. various combined activities such as turning pages, distributing cards, washing up, folding laundry, sweeping floor;
3. strengthening exercises such as gross motor exercises for trunk, arm, hand and fingers with and without weights.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change in Action Research Arm Test (ARAT) scores
timeFrame: Participants will be tested at baseline, week 3 and week 12.
Secondary outcomes:
measure: Fugl- Meyer Assessment- Upper Extremity
timeFrame: Participants will be tested at baseline, week 3 and week 12.
measure: Motor Assessment Scale items 3, 6, 7, and 8
timeFrame: Participants will be tested at baseline, week 3 and week 12.
measure: Nine-peg-hole test
timeFrame: Participants will be tested at baseline, week 3 and week 12.
measure: Grip-strength / Dynamometer
timeFrame: Participants will be tested at baseline, week 3 and week 12.
measure: EQ-5D Instrument
timeFrame: Participants will be tested at baseline, week 3 and week 12.
measure: Modified Ashworth Scale
timeFrame: Participants will be tested at baseline, week 3 and week 12.
measure: Borg scale
timeFrame: Participants will be tested after each training session at the institution, and upon completion of the intervention.
measure: Subjective evaluation of the exercise program and the use of orthotic device
timeFrame: Participants will be interviewed at week 3 and week 12.
measure: Registration data
timeFrame: Baseline
measure: functional near infrared spectroscopy (fNIRS)
timeFrame: Participants will be tested at baseline, week 3 and week 12.
Other outcomes:
Locations:
city: Rykkin
country: Norway
facility: Unicare Fram
Study officials:
affiliation: Sunnaas Rehabilitation Hospital
name: Johan K Stanghelle, MD, PhD
role: STUDY_DIRECTOR
References: