The Technology-assisted, High Intensive, Task-oriented Exercise Trial

NCT ID: NCT03396939

Last Updated: 2020-04-16

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-10
• Study Completion Date: 2020-06-30

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.

Conditions

Stroke; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Vascular Diseases; Nervous System Diseases; Cerebral Infarction; Brain Ischemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Orthosis

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.

Group Type: EXPERIMENTAL

Orthosis

Intervention Type: 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.

Control

The group will receive the same amount of a study-specific training program without the orthotic device.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Orthosis

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unicare Fram

UNKNOWN

Sponsor Role: collaborator

SunHF Aker Polklinikk

UNKNOWN

Sponsor Role: collaborator

Sunnaas Rehabilitation Hospital

OTHER

Sponsor Role: lead

Responsible Party

Yih Wong

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Johan K Stanghelle, MD, PhD

Role: STUDY_DIRECTOR

Sunnaas Rehabilitation Hospital

Locations

Unicare Fram

Rykkin, , Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 37501217 (View on PubMed)

Other Identifiers

2017/1915 D

Identifier Type: -

Identifier Source: org_study_id