Testing a new rehabilitation belt to help patients walk early after chest surgery

ISRCTN	ISRCTN32854224
DOI	https://doi.org/10.1186/ISRCTN32854224
Sponsor	Chongqing University Cancer Hospital
Funder	Chongqing University Cancer Hospital

Submission date: 20/08/2026
Registration date: 27/08/2026
Last edited: 24/08/2026

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Surgery

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mrs Qiuxia Liu
Principal investigator, Public, Scientific

No. 181 Hanyu Road, Shapingba District
Chongqing
400030
China

Phone	+86 (0)17382937847
Email	471519103@qq.com

Study information

Primary study design	Interventional
Allocation	Randomized controlled trial
Masking	Open (masking not used)
Control	Active
Assignment	Parallel
Purpose	Device feasibility
Scientific title	The design and clinical application of a multifunctional rehabilitation belt for early ambulation after thoracic surgery: a cluster randomized controlled trial
Study objectives	To design a multifunctional rehabilitation belt and evaluate its clinical efficacy in promoting early ambulation in patients after thoracic surgery.
Ethics approval(s)	Submitted 15/05/2024, Ethics Committee of Chongqing University Cancer Hospital (Department of Thoracic Oncology, No. 181 Hanyu Road, Chongqing, 400030, China; +86 (0)23 65075696; liuqiuxia@edu.com), ref: CZLS2024252-A-19
Health condition(s) or problem(s) studied	Postoperative recovery after video-assisted thoracoscopic surgery (VATS) for thoracic malignancy
Intervention	Two wards were randomized using a random digit table: Ward 1 was allocated to the experimental group and Ward 2 to the control group. Cluster randomisation was performed before participant enrolment. Experimental group: Multifunctional rehabilitation belt (bilateral assistive straps, transverse grip bands, detachable grip rings, and adjustable connecting mechanism) for postoperative position shifting and upper-extremity isometric resistance training. Control group: Conventional gauze assistive belt (155 cm standard gauze traction band) fixed to bed rails for passive patient repositioning assistance. The intervention was delivered from postoperative day 1 until hospital discharge (typically 3–7 days post-surgery). Each patient received at least three daily sessions of position training combined with grip strength exercises.
Intervention type	Device
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Multifunctional rehabilitation belt
Primary outcome measure(s)	Postoperative time to get out of bed (minutes) measured using using a stopwatch from initiating self-support to stable standing with both feet on the floor at postoperative days 1-3 (first 10 mobilization attempts recorded) Chest drainage tube extubation time measured using days from surgery completion to tube removal at postoperative period until discharge Comfort score during repositioning measured using a 0-10 Numerical Rating Scale at each position change session on postoperative days 1-3 Device-related adverse events measured using structured daily monitoring checklist at throughout intervention period
Key secondary outcome measure(s)
Completion date	31/12/2024

Eligibility

Participant type(s)
Age group	Mixed
Lower age limit	18 Years
Upper age limit	75 Years
Sex	All
Target sample size at registration	120
Total final enrolment	120
Key inclusion criteria	1. Aged 18-75 years 2. Elective VATS for confirmed thoracic malignancy 3. At least one thoracic drainage tube retained postoperatively 4. Intact language and cognitive function 5. Stable vital signs and voluntary participation with signed informed consent
Key exclusion criteria	1. Myasthenia gravis, severe arthritis, or other disorders impairing upper-limb gripping 2. Severe cardiopulmonary, hepatic, renal, coagulation, or autoimmune comorbidities 3. Postoperative activity restrictions ordered by surgeons 4. Cognitive or communication disorders 5. Known allergies to the belt's raw materials
Date of first enrolment	01/06/2024
Date of final enrolment	31/12/2024

Locations

Countries of recruitment

China

Study participating centres

Results and Publications

Individual participant data (IPD) Intention to share	No

Editorial Notes

24/08/2026: Study's existence confirmed by the Ethics Committee of Chongqing University Cancer Hospital.