Effects of Appropriate Technology for Home-based Rehabilitation in Patients With Post-stroke Physical Dysfunction

NCT06437587 | Recruiting

• 1 other identifier: HMUDQ20231116205
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to assess the effect of S-HRAT to improve patients' motor function and activities of daily living.

Conditions

Stroke

Keywords

home-based rehabilitation; appropriate technology

Outcome Measures

Primary Outcomes (2)

• Motor Function

  The motor function of the patients is measured using the Motor Assessment Scale (MAS) for stroke. MAS is methodologically simple, targeted, and easily generalizable for motor function assessment in stroke patients, as well as reliable and valid. The scale consists of nine items, each of which is scored from 0 to 6 out of 48, with the ninth item not scoring. Higher scores indicate better motor function.

  baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).

• Balance

  Balance was measured using the Berg Balance Scale (BBS). The scale consists of 14 items, including sitting to standing, standing independently, walking independently, and standing to sit, and each item is scored on five functional levels: 0, 1, 2, 3, and 4. A score of 4 indicates that the action under examination can be performed normally. In contrast, a score of 0 indicates that it cannot be performed or requires significant assistance. The total possible score is 56, with higher scores indicating better balance.

  baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).

Secondary Outcomes (4)

• Activity of Daily Living

  baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).

• Exercise Adherence

  baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).

• Patient Satisfaction

  baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).

• Anxiety and Depression

  baseline (T0), 8-week post-intervention (T1), and 12-week follow-up (T2).

Study Arms (2)

intervention group

EXPERIMENTAL

Home-based rehabilitation appropriate technology (S-HRAT) training

Other: Home-based rehabilitation appropriate technology (S-HRAT) training

control group

NO INTERVENTION

Routine discharge instructions

Interventions

Home-based rehabilitation appropriate technology (S-HRAT) training OTHER

The S-HRAT training instruction consists of two phases: in-hospital training and post-discharge remote home training. Based on the S-HRAT list, we select individualized home rehabilitation training exercises for the participants and conduct five offline training instruction sessions one week before discharge to ensure that the participants master the correct method for each exercise and clarify precautions. At discharge, participants will receive an S-HRAT brochures, which will include detailed text, pictures and video demonstrations of exercises, to visualize the rehabilitation instructions and make them easy to understand. Participants learn how to use the S-HRAT booklet and follow a daily training program to complete the prescribed content. They will be asked to record a video of their training and send it to the researcher via WeChat for monitoring purposes and feedback.

intervention group

Eligibility Criteria

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

You may qualify if:

• Age≥18;
• Patients diagnosed with cerebrovascular disease who have cerebral infarction or cerebral hemorrhage based on cranial CT or MRI and meet the diagnostic criteria;
• Patients are in the non-acute phase, meaning between two weeks and six months after the onset of the disease;
• Patients with limb dysfunction.

You may not qualify if:

• Return to a hospital or rehabilitation facility after discharge;
• The patient has a history of mental illness and dyslexia;
• Patients have a combination of serious, life-threatening conditions.

Sponsors & Collaborators

• Xi Chen: lead
• Harbin Medical University: collaborator

Study Sites (1)

Daqing Oilfield General Hospital

Daqing, Heilongjiang, 163001, China

RECRUITING

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Xi Chen

CONTACT

15945313760; chenxi3760@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Due to the nature of the intervention, it is impossible to blind the researcher of the intervention who will deliver the intervention. Therefore, the participants and the outcome assessor will be blinded. The outcome assessor will be blinded to the allocation throughout the study and will independently assess all outcomes at T0, T1, and T2 for both groups.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: researcher

Study Record Dates

• First Submitted: May 25, 2024
• First Posted: May 31, 2024
• Study Start: June 1, 2024
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: September 23, 2024

Record last verified: 2024-09

Locations

CN (1)