Providing Sitting Balance Training With a Newly Developed Rehabilitation Device

NCT04467554 | Completed DMC

• 1 other identifier: T-Chair
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is being conducted to evaluate a new training device, the T-CHAIR, for trunk rehabilitation and post-stroke balance. The investigators would like to study three objectives. First, the investigators want to examine whether training with a new training device is feasible and safe during rehabilitation in the later phase, more than six months after a stroke. The investigators also evaluate whether training with a new training device has an effect on the sitting balance and the function and strength of the trunk. Finally, the investigators examine whether training with a new training device has an effect on walking, standing and activities of daily life and self-care.

Conditions

Stroke

Keywords

Stroke; Rehabilitation; Chronic phase; feasibility; randomized controlled trial

Outcome Measures

Primary Outcomes (9)

• Recruitment

  Recruitment is characterized by the number of possible participants divided by the number of participants actually participated in the trial.

  Through study completion, an average of 1.5 months.

• Retention

  Retention is the number of participants that complete the whole trial divided by the number of participants that are included in the study.

  Through study completion, an average of 1.5 months.

• Participation

  During each therapy the therapist evaluates the participation of each candidate.

  Through study completion, an average of 1.5 months.

• Adherence

  After each therapy session the therapist evaluates the adherence using the Clinician Rating of Compliance Scale. This is a seven point ordinal scale which assesses the level of adherence of the patient. A higher score represent better adherence. A score lower than five is defined as non-adherent.

  Through study completion, an average of 1.5 months.

• Acceptability and enjoyment

  The level of enjoyment during the training will be assessed using the physical activity enjoyment scale. This scale contains 18 items, during the training participants have to score how they feel about the training on a seven-point bipolar scale. The lowest score stands for less enjoyment or acceptance, a higher score stands for maximum enjoyment or acceptance.

  Through study completion, an average of 1.5 months.

• Safety and Adverse events

  Safety is evaluated by retaining all adverse events during the therapy sessions.

  Through study completion, an average of 1.5 months.

• Device development or modifications

  Feedback from the participants and therapists to improve the device are noted after every session. Each patient and therapist who came in contact with the device received an experience questionnaire. The questionnaire contains 16 questions, 3 questions and 13 categorical questions on 5 or 7 point Likert scale.

  Through study completion, an average of 1.5 months.

• Fatigue

  After each training session fatigue will be evaluated using Visual Analog Fatigue Scale.This scale consists of a 10 cm horizontal line with written description at each end of the line. The written description varies from no fatigue to Very Severe Fatigue on top of the 10 cm line.

  Through study completion, an average of 1.5 months.

• Patient Global Impression of Change

  The patient Global impression of change is a one single question to rate their condition after the therapy sessions compared to the rate of their condition at the start of the therapy session. This scale will be evaluated twice. One time after two weeks of intervention and once after the four weeks of intervention.

  Through study completion, an average of 1.5 months.

Secondary Outcomes (11)

• Trunk function

  Through study completion, an average of 1.5 months.

• Trunk stability

  Through study completion, an average of 1.5 months.

• Trunk strength

  Through study completion, an average of 1.5 months.

• Sitting balance

  Through study completion, an average of 1.5 months.

• Walking speed

  Through study completion, an average of 1.5 months.

Study Arms (2)

Measurements and T-chair training

EXPERIMENTAL

This group will receive three measurements sessions and training with a new developed device (15 therapy sessions in total).

Device: T-chair

Measurements

NO INTERVENTION

This group will receive three measurements sessions.

Interventions

T-chair DEVICE

Participants will receive 15 sessions of intervention, four weeks in total with a duration of one hour for each session. The focus of the intervention will be trunk rehabilitation.

Measurements and T-chair training

Eligibility Criteria

• Age: 18 Years - 110 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• First major stroke event, a transient ischemic attack or a previous stroke with full recovery is allowed.
• Impairment of the trunk function, with a maximum score of 19 on the trunk impairment scale .
• Able to maintain seated position for more than 10 seconds.
• Able to come to the rehabilitation ward as a chronic patient.
• More than six months after a stroke event.
• Older than 18 years.
• With no comorbidities other than stroke affecting trunk function. Comorbidities could be musculoskeletal problems or other neurological diseases.
• With sufficient cognitive and language capacity to perform the assessment.

You may not qualify if:

• Not able to give informed consent.
• Not approved informed consent.
• Subject does not understand the study procedures.
• Subject has any history of another major neurological disorder.

Sponsors & Collaborators

• KU Leuven: lead

Study Sites (1)

Liselot Thijs

Leuven, 3000, Belgium

Location

Related Publications (1)

• Thijs L, Voets E, Wiskerke E, Nauwelaerts T, Arys Y, Haspeslagh H, Kool J, Bischof P, Bauer C, Lemmens R, Baumgartner D, Verheyden G. Technology-supported sitting balance therapy versus usual care in the chronic stage after stroke: a pilot randomized controlled trial. J Neuroeng Rehabil. 2021 Jul 28;18(1):120. doi: 10.1186/s12984-021-00910-7.

  PMID: 34321042 DERIVED

Related Links

• Open access

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Study Design

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

Model Details: Pilot randomized controlled trial

Study Record Dates

• First Submitted: June 29, 2020
• First Posted: July 13, 2020
• Study Start: July 17, 2020
• Primary Completion: December 18, 2020
• Study Completion: July 13, 2021
• Last Updated: January 28, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)