Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Brain Diseases
  • Brain Ischemia
  • Central Nervous System Diseases
  • Cerebral Infarction
  • Cerebrovascular Disorders
  • Nervous System Diseases
  • Stroke
  • Vascular Diseases
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention 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 (Outcomes Assessor)Masking Description: Assessments of the study population are performed at baseline, at the end of week 3, at week 12 upon completion of the intervention. A "blinded" therapist, not involved in the project, will perform all the testing.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

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 consequen...

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.

Tracking Information

NCT #
NCT03396939
Collaborators
  • Unicare Fram
  • SunHF Aker Polklinikk
Investigators
Study Director: Johan K Stanghelle, MD, PhD Sunnaas Rehabilitation Hospital