Effectiveness of exoskeleton training on turning-while-walking and balance control in subjects with incomplete spinal cord injury: protocol for a randomised clinical trial.

The study is designed as a multicentre, cluster RCT comparing three intervention groups over 12 weeks in individuals with ambulatory incomplete spinal cord injury (iSCI).

• Three groups are compared: (1) overground exoskeleton training group, (2) conventional training group, and (3) usual care group.
• The intervention duration is 12 weeks for all three groups.
• Participants will be recruited from three centres in Hong Kong SAR and mainland China.
• The trial is registered under ClinicalTrials.gov identifier NCT06971510.

Primary outcomes focus on turning-while-walking performance, measured by turning duration and number of steps during a 2-m turning-while-walking test.

• The primary outcomes are turning duration and number of steps during a 2-m turning-while-walking test.
• Individuals with iSCI often experience impaired balance control and turning-while-walking ability, which increase the risk of falls and limit community mobility.
• Assessments will be conducted at baseline, mid-intervention, postintervention, and at a 1-month follow-up.

Secondary outcomes encompass a broad range of physical and psychosocial measures relevant to iSCI rehabilitation.

• Secondary outcomes include static and dynamic balance, sensorimotor integration, gait performance, muscle strength, and spasticity.
• Additional secondary outcomes include quality of life, self-efficacy, and fall incidence.
• Assessments are planned at four time points: baseline, mid-intervention, postintervention, and 1-month follow-up.

The rationale for the trial is that evidence from randomised controlled trials on exoskeleton-assisted ambulation in individuals with iSCI remains limited, despite promising preliminary findings.

• Overground exoskeleton training has shown promise in improving gait and balance in individuals with iSCI.
• The authors note that 'evidence from randomised controlled trials (RCTs) on ambulation of individuals with iSCI remains limited.'
• Impaired balance and turning-while-walking increase fall risk and limit community mobility in this population.

The study has received ethics approval from multiple institutional review boards across Hong Kong and mainland China.

• Ethics approval was obtained from the Research Ethics Committees of Hong Kong Metropolitan University, the Affiliated BenQ Hospital of Nanjing Medical University, and Changzhou Sunshine Rehabilitation Hospital.
• Written informed consent will be obtained from all participants before enrolment.
• Study findings will be disseminated through peer-reviewed publications, conference presentations, and summaries available to participants upon request.