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

NCT03396939 | Unknown DMC

• 1 other identifier: 2017/1915 D
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  Participants will be tested at baseline, week 3 and week 12.

Secondary Outcomes (10)

• Fugl- Meyer Assessment- Upper Extremity

  Participants will be tested at baseline, week 3 and week 12.

• Motor Assessment Scale items 3, 6, 7, and 8

  Participants will be tested at baseline, week 3 and week 12.

• Nine-peg-hole test

  Participants will be tested at baseline, week 3 and week 12.

• Grip-strength / Dynamometer

  Participants will be tested at baseline, week 3 and week 12.

• EQ-5D Instrument

  Participants will be tested at baseline, week 3 and week 12.

Study Arms (2)

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.

Device: Orthosis

Control

NO INTERVENTION

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

Interventions

Orthosis 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.

Orthosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sunnaas Rehabilitation Hospital: lead
• Unicare Fram: collaborator
• SunHF Aker Polklinikk: collaborator

Study Sites (1)

Unicare Fram

Rykkin, 1349, Norway

Location

Related Publications (1)

• 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.

  PMID: 37501217 DERIVED

MeSH Terms

Conditions

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

Interventions

Orthotic Devices

Condition Hierarchy (Ancestors)

Cardiovascular Diseases; Brain Infarction; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Officials

• Johan K Stanghelle, MD, PhD

  Sunnaas Rehabilitation Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 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.

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 11, 2018
• Study Start: January 10, 2018
• Primary Completion: December 20, 2019
• Study Completion: June 1, 2020
• Last Updated: April 16, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)