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Completed

NCT Number: NCT03273101

Sit-to-stand Training in Stroke Patient

Background: It is unknown whether the self-initiated sit-to-stand training with assistive device is effective to regain the independence of sit-to-stand in stroke patients.

Objective: To compare the effectiveness of self-initiated sit-to-stand training by assistive device, with manual sit-to-stand training.

Design: Parallel randomised controlled and assessor blinded trial between Jan 2015 and May 2018. Randomisation was performed by drawing lots to allocate treatment to patient.

Setting: A rehabilitation hospital in Hong Kong

Participants: 69 patients in medical wards with unilateral hemiparetic stroke. 52 patients fulfilled the study requirements.

Intervention: Ten sessions of intervention with conventional physiotherapy program followed, by self-initiated sit-to-stand training with assistive device, or by manual sit-to-stand training.

Main outcome measure: Number of patients regained the independence of sit-to-stand, Sit-to-stand test from the balance master® and Five-repetitions sit-to-stand test.

Results: 69 patients (intervention n=36; control n=33) were randomized (mean age 69.8 (SD, 10.6), mean post stroke days 18.6 (SD 16.0)) for intention to treat analysis. 17 patients were excluded because of dropout before 10 sessions of training, leaving 52 (n=26; n=26) patients for per protocol analysis. 18 patients in intervention group and 10 patients in control group had regained the independence of sit-to-stand (Phil and Cramer's V: -0.31 and 0.31). The patients in intervention group were faster to complete the Five-repetition sit-to-stand test than the control group (32.7 secs (SD, 1.93) v 48.4 secs (SD, 6.8); 95% confidence interval, -30.8 to -0.7; p<0.05). No adverse side effects occurred during and after the training across groups.

Conclusions: Self-initiated sit-to-stand training by assistive device can help more stroke patients regain the independence of sit-to-stand.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • first episode of unilateral stroke with hemiparesis,
  • able to understand and follow simple verbal instructions,
  • able to sit unsupported for at least two minutes
  • require lifting assistance to stand up from a 18 inches high plinth

Exclusion criteria

  • severe pain in the lower extremities when weight bearing or performing movement
  • any other acute comorbid diseases such as unstable angina, recent myocardial infarction
  • unstable medical / psychological condition

Treatment and study plan

Mechanical assisted sit-to-stand training group

Device

Mechanical assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions

Other names: sit-to-stand trainer

Manual assisted sit-to-stand training group

Other

Manual assisted sit-to-stand training 100 repetitions or 10 mins / session 10 sessions

Other names: physiotherapist assisted

Primary outcomes

  1. Number of patients regained the independence of sit-to-stand

    Time frame: After 10 sessions of training

    To compare how many patients can regain the independence of sit-to-stand between groups

  2. Sit-to-Stand Test (SST) from the Balance Master®

    Time frame: After 10 sessions of training

    To assess the quality of sit-to-stand of patient

  3. Five-Repetition Sit-to-Stand Test

    Time frame: After 10 sessions of training

    To assess the functional strength of lower limb, balance and transition move of patient

Sponsors and collaborators

Lead sponsor

Tai Po Hospital

Other Gov

Registry information

Official study title

Does Self-initiated Sit-to-stand Training With Assistive Device Regain the Independence of Sit-to-stand in Stroke Patient? A Single-blinded Randomised Controlled Trial.

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Sep 6, 2017
Registry last updated
Sep 6, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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